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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1575 NORTHSIDE DR NW STE 440, Atlanta, GA, 30318
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3007593722
- DUNS Number
- 601306413
Catalogue (563)
Page 1 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Kitsune | 2800-02-018 | FDA UDI | Class I | Active |
| DynaClip | 3000-03-020 | FDA UDI | Class I | Active |
| Quick Connect Handle, Mini, Ratcheting | 2100-04-001 | FDA UDI | Class I | Active |
| Acorn Reamer, 8.5mm | 2300-01-085 | FDA UDI | Class I | Active |
| DynaClip | 3000-05-018 | FDA UDI | Class I | Active |
| Ef1 | 6206-0002100-00 | FDA UDI | Class I | Active |
| DynaNail | 2201-06-0090 | FDA UDI | Class I | Active |
| DynaClip Delta | 3000-10-28161412 | FDA UDI | Class II | Active |
| DynaClip Delta | 3000-08-032 | FDA UDI | Class I | Active |
| DynaNail | 1200-01-1230 | FDA UDI | Class II | Active |
| Acorn Reamer, 9.5mm | 2300-01-095 | FDA UDI | Class I | Active |
| DynaNail | 2200-26-0000 | FDA UDI | Class I | Active |
| ExoShape | 1101-00-1030 | FDA UDI | Class II | Active |
| Drill, variable size, wolverine, DynaClip staple, 3.0mm | ED-10877-030 | FDA UDI | Class I | Active |
| DynaNail Mini | 2900-01-0201 | FDA UDI | Class I | Active |
| DynaNail Mini | 2900-10-0000 | FDA UDI | Class I | Active |
| DynaNail | 2200-23-0000 | FDA UDI | Class I | Active |
| Ef1 | DNE-312030 | FDA UDI | Class II | Active |
| DynaNail | 1200-02-5035 | FDA UDI | Class II | Active |
| Morphix | 1000-03-335 | FDA UDI | Class II | Active |
| DynaNail Mini | 2600-03-4320 | FDA UDI | Class II | Active |
| DynaNail Mini | 2600-00-8120 | FDA UDI | Class II | Active |
| DynaNail Hybrid | 2601-00-7100 | FDA UDI | Class II | Active |
| Evolve34 | 3400-06-000 | FDA UDI | Class I | Active |
| Ef1 | DNE-27-TR | FDA UDI | Class II | Active |
| Ef1 | DNE-4-HFB | FDA UDI | Class II | Active |
| DynaNail | 1200-03-5105 | FDA UDI | Class II | Active |
| Ef1 | DNE-9010-200S | FDA UDI | Class I | Active |
| Ef1 | DNE-9000-600-CF | FDA UDI | Class II | Active |
| DynaNail | 2200-19-0020 | FDA UDI | Class I | Active |
| DynaNail Helix, Headless, 95mm | 3200-01-7095 | FDA UDI | Class II | Active |
| DynaClip Delta | 3000-08-028 | FDA UDI | Class I | Active |
| DynaNail Mini | 2600-05-0003 | FDA UDI | Class II | Active |
| Ef1 | DNE-6000-001 | FDA UDI | Class II | Active |
| Ef1 | DNE-9000-300-CF | FDA UDI | Class II | Active |
| Reusable Instrument Sterilization Tray, Lapidus Instrumentation | 3400-15-000 | FDA UDI | Class I | Active |
| DynaNail | 2200-27-0000 | FDA UDI | Class I | Active |
| ExoShape Femoral | 1600-00-008 | FDA UDI | Class II | Active |
| DynaNail Mini | 2600-04-4332 | FDA UDI | Class II | Active |
| DynaNail Mini | 2600-00-7110 | FDA UDI | Class II | Active |
| Ef1 | 14-1156-R0 | FDA UDI | Class II | Active |
| ExoShape | 1101-00-1130 | FDA UDI | Class II | Active |
| DynaNail | 1200-02-5025 | FDA UDI | Class II | Active |
| DynaNail | 1200-02-5020 | FDA UDI | Class II | Active |
| DynaNail Mini | 2900-17-0001 | FDA UDI | Class I | Active |
| Ef1 | DNE-200-5 | FDA UDI | Class II | Active |
| Ef1 | 1499-000-001 | FDA UDI | Class I | Active |
| DynaClip Forte | 3000-04-000 | FDA UDI | Class I | Active |
| Pin, 3.0mm, DynaClip Staple, 2.0mm | ED-10801-020 | FDA UDI | Class II | Active |
| Evolve34 | 3400-07-000 | FDA UDI | Class I | Active |
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 2, 2025 | Z-2513-2025 | — | open, classified | Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use. |
| Nov 17, 2021 | Z-0453-2022 | — | open, classified | The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure. |