Keele, GB · 4 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | 2 | 2025-04-07 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Class II | Orthopedic | 1 | 2026-02-17 |
| KWL | — | — | — | 1 | 2025-06-12 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-11-12 | Class II | Terminated | Z-0638-2021 | Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not … | — | The product is mislabeled. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-02-17 | K251680 | Biosteon® Screw | MAI | Class II | Orthopedic |
| 2025-06-12 | K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | KWL | — | — |
| 2025-04-07 | K250521 | NanoBone® SBX Putty ; NanoBone® QD | MQV | Class II | Orthopedic |
| 2022-02-04 | K212721 | Genex Bone Graft Substitute | MQV | Class II | Orthopedic |