DEVICE CLASS
Class II
REGULATION
21 CFR 888.3030
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES
Recent clearances
K253115Movmedix S.A.S. · 510k2026-06-10
K252081Lincotek Medical · 510k2026-03-27
K253727Arthrex, Inc. · 510k2025-12-22
K251643Wright Medical Technology, Inc. (Stryker Corporation) · 510k2025-10-29
K251134TriMed, Inc. · 510k2025-07-11
K243624Acumed, LLC · 510k2025-01-23
K242091Fusion Orthopedics · 510k2024-12-23
K243408Vilex, LLC · 510k2024-11-27
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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