Alachua, FL, US · 3 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | Class II | General, Plastic Surgery | 2 | 2025-10-22 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | 1 | 2025-02-21 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-10-22 | K253145 | Pre-Sutured Tendon | GAT | Class II | General, Plastic Surgery |
| 2025-02-21 | K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | MQV | Class II | Orthopedic |
| 2023-06-23 | K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) | GAT | Class II | General, Plastic Surgery |