Panels › General, Plastic Surgery › Product code GCZ · Class 1
Retainer, Surgical
Regulation 878.4800
0510(k)s in 12 months (5 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in GCZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Folsom Metal Products, Inc. | 0 | 6 |
| Adept-Med Intl., Inc. | 3 | 0 |
| Edward Weck, Inc. | 1 | 0 |
| Jain Surgical Equipment, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2025 | Folsom Metal Products, Inc. Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile Open, Classified |
GCZ | None listed |
| Sep 17, 2025 | Folsom Metal Products, Inc. Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile Open, Classified |
GCZ | None listed |
| Sep 17, 2025 | Folsom Metal Products, Inc. Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile Open, Classified |
GCZ | None listed |
| Sep 17, 2025 | Folsom Metal Products, Inc. Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile Open, Classified |
GCZ | None listed |
| Sep 17, 2025 | Folsom Metal Products, Inc. Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile Open, Classified |
GCZ | None listed |
| Sep 17, 2025 | Folsom Metal Products, Inc. Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile Open, Classified |
GCZ | None listed |
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