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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 8 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DynaNail Helix, Headed, 60mm | 3200-00-7060 | FDA UDI | Class II | Active |
| Ef1 | DNE-12-B | FDA UDI | Class II | Active |
| Ef1 | 14-1188-R0 | FDA UDI | Class II | Active |
| Ef1 | DNE-40-TR | FDA UDI | Class II | Active |
| Universal Joints | DNE-9000-UJ | FDA UDI | Class II | Active |
| Eclipse | 1500-01-060 | FDA UDI | Class I | Active |
| Ef1 | DNE-160-34 | FDA UDI | Class II | Active |
| DynaClip | 3000-00-101010 | FDA UDI | Class II | Active |
| Ef1 | DNE-140-DXFP | FDA UDI | Class II | Active |
| DynaClip | 3000-03-008 | FDA UDI | Class I | Active |
| Ef1 | DNE-9000-ST | FDA UDI | Class I | Active |
| ExoShape Teno | 1100-01-0620 | FDA UDI | Class II | Active |
| Removal Driver, DynaFuse | 3100-00-0020 | FDA UDI | Class I | Active |
| DynaClip Forte | 3000-06-302020 | FDA UDI | Class II | Active |
| Ef1 | DNE-1000-AW | FDA UDI | Class I | Active |
| DynaNail | 2200-05-0090 | FDA UDI | Class I | Active |
| Ef1 | DNE-150-TR | FDA UDI | Class II | Active |
| Ef1 | DNE-9000-250-PTB | FDA UDI | Class II | Active |
| Ef1 | DNE-4-PL | FDA UDI | Class II | Active |
| Ef1 | DNE-240-DXFP | FDA UDI | Class II | Active |
| DynaNail Helix, Headed, 80mm | 3200-00-7080 | FDA UDI | Class II | Active |
| Ef1 | DNE-5-FP | FDA UDI | Class II | Active |
| Ef1 | DNE-30-B | FDA UDI | Class II | Active |
| Eclipse | 2300-01-080 | FDA UDI | Class I | Active |
| DynaNail | 2200-03-0162 | FDA UDI | Class I | Active |
| Eclipse | 1500-00-0812 | FDA UDI | Class II | Active |
| Eclipse | 1500-00-0410 | FDA UDI | Class II | Active |
| DynaNail Mini | 2600-04-4322 | FDA UDI | Class II | Active |
| Double-Ended Paddle Retractor | 3400-18-000 | FDA UDI | Class I | Active |
| ExoShape | 1100-00-0730 | FDA UDI | Class II | Active |
| ExoShape | 1100-00-1030 | FDA UDI | Class II | Active |
| Ef1 | DNE-4050-300 | FDA UDI | Class II | Active |
| Ef1 | DNE-6000-036 | FDA UDI | Class II | Active |
| Ef1 | DNE-160-DHFP | FDA UDI | Class II | Active |
| DynaClip Delta | 3000-08-024 | FDA UDI | Class I | Active |
| Ef1 | DNE-16-B | FDA UDI | Class II | Active |
| DynaClip Quattro | 3000-09-018 | FDA UDI | Class I | Active |
| DynaNail | 2200-24-0001 | FDA UDI | Class I | Active |
| DynaClip | 3000-00-121212 | FDA UDI | Class II | Active |
| ExoShape | 1101-00-0930 | FDA UDI | Class II | Active |
| DynaNail | 2200-11-0001 | FDA UDI | Class I | Active |
| DynaNail | 2200-02-0000 | FDA UDI | Class I | Active |
| DynaNail Mini | 2900-14-0000 | FDA UDI | Class I | Active |
| Eclipse | 1500-01-050 | FDA UDI | Class I | Active |
| Helical Ridge | 1400-17-0475 | FDA UDI | Class II | Active |
| Item Master, Cannulated Reusable Driver, Helical Ridge | 2400-00-000 | FDA UDI | Class I | Active |
| DynaNail | 2200-08-2540 | FDA UDI | Class I | Active |
| DynaNail | 2201-06-0110 | FDA UDI | Class I | Active |
| DynaNail Mini | 2900-12-0000 | FDA UDI | Class I | Active |
| DynaNail Mini | 2900-05-0006 | 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. |