{
  "format": "devicerts.device.v1",
  "cite_as": "2.0 System 95-2019T, Biomet Microfixation, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/2-0-system-95-2019t (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/2-0-system-95-2019t",
    "json_url": "https://devicerts.com/devices/2-0-system-95-2019t.json",
    "markdown_url": "https://devicerts.com/devices/2-0-system-95-2019t.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-11-07",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/2-0-system-95-2019t",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "2.0 System 95-2019T",
    "registry_name": "2.0 SYSTEM 95-2019T",
    "url": "https://devicerts.com/devices/2-0-system-95-2019t",
    "manufacturer": {
      "name": "Biomet Microfixation, Inc",
      "url": "https://devicerts.com/manufacturers/biomet-microfixation-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class IIb",
        "system": "EU MDD"
      },
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Catalogue number",
        "values": [
          {
            "value": "95-2019T",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "00841036056377",
            "registries": [
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              "FDA GUDID (AccessGUDID)"
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          }
        ]
      },
      {
        "label": "Basic UDI-DI",
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          {
            "value": "B-00841036056377",
            "registries": [
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            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K121589",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          },
          {
            "value": "K953385",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "JEY"
    ],
    "emdn": [
      {
        "code": "P09120503",
        "term": "OSTEOSYNTHESIS SCREW-PLATE SYSTEMS"
      }
    ],
    "gmdn": [
      {
        "code": "56642",
        "term": "Orthopaedic bone screw, non-bioabsorbable, non-sterile"
      }
    ],
    "description": null,
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDD",
      "number": "B-00841036056377",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "00841036056377",
      "date": "2026-10-27",
      "date_kind": "registered",
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      "status_note": null,
      "derived_from_gudid": false
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    {
      "registry": "GUDID",
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      "type": "GUDID listing",
      "number": "00841036056377",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2015-10-11",
      "date_kind": "listed",
      "decision_code": null,
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      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K121589",
      "number_label": null,
      "device_udi_di": null,
      "date": "2012-09-21",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K953385",
      "number_label": null,
      "device_udi_di": null,
      "date": "1995-09-28",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1220-2017",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-01-10",
      "reason": "The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.",
      "applies": "shared submission",
      "via": "K121589"
    },
    {
      "number": "Z-0835-2012",
      "classification": "",
      "status": "terminated",
      "initiated": "2010-11-08",
      "reason": "On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120)   packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet 1 count (REF 99-7204, Lot 202450) and 5 count packages (REF 01/7204, Lot 202450) of the 1.5MM System Center-Drive Screw, 5/Pk because of a possibility that thes",
      "applies": "shared submission",
      "via": "K953385"
    },
    {
      "number": "Z-0836-2012",
      "classification": "",
      "status": "terminated",
      "initiated": "2010-11-08",
      "reason": "On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120)   packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet 1 count (REF 99-7204, Lot 202450) and 5 count packages (REF 01/7204, Lot 202450) of the 1.5MM System Center-Drive Screw, 5/Pk because of a possibility that thes",
      "applies": "shared submission",
      "via": "K953385"
    },
    {
      "number": "Z-2385-2011",
      "classification": "",
      "status": "terminated",
      "initiated": "2010-07-28",
      "reason": "Biomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y,  Lots 785710, 753120, 693500 and 733600. This product is labeled as 01-7110-K (1.5 6 Hole Reg Double Y), however the package contains a 01-7112-K (1.5.6 Hold Long Double Y).",
      "applies": "this device",
      "via": "K953385"
    },
    {
      "number": "Z-2873-2011",
      "classification": "",
      "status": "terminated",
      "initiated": "2010-05-17",
      "reason": "On May 17, 2010, Biomet Microfixation issued a Safety Alert on their Thinflap System Cross Drive, Self Drilling Screw, 1.5x4mm, Model #: 91-6704, Lot#: 173770. The product is labeled incorrectly. Some packages of 91-6704 lot 173770 are labeled as cross drive screws, but contain center drive screws.  All affected customers were notified of the recall on May 17, 2010.",
      "applies": "shared submission",
      "via": "K953385"
    },
    {
      "number": "Z-1286-2012",
      "classification": "",
      "status": "terminated",
      "initiated": "2010-04-26",
      "reason": "On 4/26/10 Biomet Microfixation, Jacksonville, FL  initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690.  Product is labeled incorrectly.",
      "applies": "this device",
      "via": "K953385"
    },
    {
      "number": "Z-2206-2010",
      "classification": "",
      "status": "terminated",
      "initiated": "2010-03-17",
      "reason": "Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.",
      "applies": "shared submission",
      "via": "K953385"
    },
    {
      "number": "Z-1151-2010",
      "classification": "",
      "status": "terminated",
      "initiated": "2009-10-06",
      "reason": "Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw.",
      "applies": "this device",
      "via": "K953385"
    },
    {
      "number": "Z-1943-2010",
      "classification": "",
      "status": "terminated",
      "initiated": "2009-10-05",
      "reason": "Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760.  This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.",
      "applies": "this device",
      "via": "K953385"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Trade name",
          "values": [
            {
              "value": "2.0 SYSTEM",
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                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Generic name",
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                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Model / Ref / Catalog",
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          ]
        },
        {
          "label": "GMDN term",
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              "value": "Orthopaedic bone screw, non-bioabsorbable, non-sterile",
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                "FDA GUDID (AccessGUDID)"
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        {
          "label": "EU registration type",
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            }
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        },
        {
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        {
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            {
              "value": "Moist Heat or Steam Sterilization",
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            }
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    {
      "group": "Properties",
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          "label": "Sterilise before use",
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              "value": "Yes",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
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            }
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        {
          "label": "Single use",
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              "registries": [
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            }
          ]
        },
        {
          "label": "Implantable",
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              "registries": [
                "EUDAMED"
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            {
              "value": "No",
              "registries": [
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            }
          ]
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        {
          "label": "Lot / batch number",
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            }
          ]
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        {
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              "registries": [
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          ]
        },
        {
          "label": "Contains latex",
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              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
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            }
          ]
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          "label": "Reprocessed single-use device",
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              "registries": [
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        {
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              "registries": [
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          "label": "Incorporates a substance derived from human blood or plasma",
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            }
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        {
          "label": "Contains human tissues or cells",
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            }
          ]
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        {
          "label": "Contains animal tissues or cells",
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        {
          "label": "Contains endocrine-disrupting substances",
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              "registries": [
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        {
          "label": "Administering medicine",
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              "registries": [
                "EUDAMED"
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            }
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        {
          "label": "Measuring function",
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              "registries": [
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            }
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        {
          "label": "Incorporates a medicinal substance",
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              "registries": [
                "EUDAMED"
              ]
            }
          ]
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        {
          "label": "Over-the-counter",
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              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
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        {
          "label": "Combination product",
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              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "HCT/P",
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              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
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        {
          "label": "Premarket exempt",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Serial number",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Expiration date",
          "values": [
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              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Manufacturing date",
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              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        }
      ]
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}