Atlanta, GA, US · 7 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | 4 | 2026-03-18 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | 2 | 2022-08-19 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | 1 | 2025-09-12 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-06-02 | Class II | Ongoing | Z-2513-2025 | Medshape Universal Joints, REF: DNE-9000-UJ | — | 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… |
| 2021-11-17 | Class II | Ongoing | Z-0453-2022 | DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile | — | The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introduci… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-18 | K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | HWC | Class II | Orthopedic |
| 2025-09-12 | K250628 | DynaNail TTC Fusion System | HSB | Class II | Orthopedic |
| 2024-03-21 | K240530 | DynaNail Mini Tapered Hybrid | HWC | Class II | Orthopedic |
| 2022-08-19 | K220812 | DynaClip® Bone Staple | JDR | Class II | Orthopedic |
| 2022-01-04 | K203595 | DynaFuse Fixation System | HWC | Class II | Orthopedic |
| 2021-01-15 | K203381 | Dynanail Mini Hybrid | HWC | Class II | Orthopedic |
| 2020-04-23 | K193305 | DynaClip Bone Staple | JDR | Class II | Orthopedic |