Folsom Metal Products, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 1
- Inspections
- 10
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2576-2025 | Class II | Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile | August 21, 2025 |
| Z-2581-2025 | Class II | Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile | August 21, 2025 |
| Z-2577-2025 | Class II | Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile | August 21, 2025 |
| Z-2579-2025 | Class II | Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile | August 21, 2025 |
| Z-2580-2025 | Class II | Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile | August 21, 2025 |
| Z-2578-2025 | Class II | Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile | August 21, 2025 |
| Z-0650-2025 | Class II | DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3. | October 30, 2023 |
| Z-0651-2025 | Class II | Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two siz | October 30, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K100205 | FRONTIER DEVICES NEURO SYSTEM | December 13, 2010 |