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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 12 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Porous Morphix Suture Anchor With Force Fiber Suture | K130467 | FDA 510(k) | Class II | Active |
| DynaNail TTC Fusion System | K171376 | FDA 510(k) | Class II | Active |
| DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | K254110 | FDA 510(k) | Class II | Active |
| Exoshape Duo Soft Tissue Fastener | K132783 | FDA 510(k) | Class II | Active |
| Dynanail Mini Hybrid | K203381 | FDA 510(k) | Class II | Active |
| Dynanail Ankle Arthrodesis Nail | K113828 | FDA 510(k) | Class II | Active |
| DynaNail Mini | K182677 | FDA 510(k) | Class II | Active |
| Helical Ridge Peek Interference Screw | K141290 | FDA 510(k) | Class II | Active |
| DynaClip® Bone Staple | K220812 | FDA 510(k) | Class II | Active |
| Fastforward | K141420 | FDA 510(k) | Class II | Active |
| Eclipse Soft Tissue Fastener | K123350 | FDA 510(k) | Class II | Active |
| DynaClip Bone Staple | K193305 | FDA 510(k) | Class II | Active |
| DynaNail TTC Fusion System | K250628 | FDA 510(k) | Class II | 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. |