{ "format": "devicerts.device.v1", "cite_as": "SafeOp 3 AIX11240, Alphatec Spine, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/safeop-3-aix11240 (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/safeop-3-aix11240", "json_url": "https://devicerts.com/devices/safeop-3-aix11240.json", "markdown_url": "https://devicerts.com/devices/safeop-3-aix11240.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "FDA recalls", "url": "https://open.fda.gov/apis/device/recall/" } ], "registry_records_last_synced": "2026-10-23", "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/safeop-3-aix11240", "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": "SafeOp 3 AIX11240", "registry_name": "SafeOp 3 AIX11240", "url": "https://devicerts.com/devices/safeop-3-aix11240", "manufacturer": { "name": "Alphatec Spine, Inc.", "url": "https://devicerts.com/manufacturers/alphatec-spine-inc", "country": null, "country_basis": null, "fda_registration_country": "United States" }, "status": { "state": "active", "label": "Active", "detail": "United States" }, "classification": [ { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00190376517506", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K234092", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "K252842", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "GWF", "PDQ", "GXZ", "GXY", "IKN", "ETN" ], "emdn": [], "gmdn": [ { "code": "46566", "term": "Neurophysiologic monitoring system" } ], "description": null, "noindex": true }, "authorizations": [ { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K252842", "number_label": null, "device_udi_di": null, "date": "2026-01-11", "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": "GUDID listing", "number": "00190376517506", "number_label": "UDI-DI", "device_udi_di": null, "date": "2024-11-12", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K234092", "number_label": null, "device_udi_di": null, "date": "2024-04-19", "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-2793-2026", "classification": "Class II", "status": "ongoing", "initiated": "2026-05-13", "reason": "Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.", "applies": "this device", "via": "K252842" } ], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "SafeOp 3", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Neurophysiologic monitoring system", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Model / reference", "values": [ { "value": "AIX11240", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00190376517506", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K234092", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "K252842", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "GWF", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "PDQ", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "GXZ", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "GXY", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "IKN", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "ETN", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "GMDN term", "values": [ { "value": "Neurophysiologic monitoring system", "code": "46566", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class II", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Regulation number", "values": [ { "value": "882.1870", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "874.1820", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "882.1350", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "882.1320", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "890.1375", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "GUDID distribution status", "values": [ { "value": "In Commercial Distribution", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Clinical & Handling", "fields": [ { "label": "MRI safety", "values": [ { "value": "MR Unsafe", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Prescription use", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Serial number", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Single use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Over-the-counter", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Convenience kit", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Combination product", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "HCT/P", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Premarket exempt", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Lot / batch number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Expiration date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }