DEVICE CLASS
Class II
REGULATION
21 CFR 888.3045
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
30
510(K)/PMA CLEARANCES
510k: 30
0
RECALL ENTRIES
Recent clearances
K260364Geistlich Pharma AG · 510k2026-06-02
K252797Sdip Innovations Pty, Ltd. · 510k2026-05-26
K261008Stryker Spine · 510k2026-04-24
K253524Biomendex OY · 510k2026-02-17
K253147Prosidyan, Inc. · 510k2025-10-22
K251522Bone Solutions, Inc. · 510k2025-10-13
K252085Wright Medical Technology, Inc. (Stryker Corporation) · 510k2025-09-30
K251556Geistlich Pharma AG · 510k2025-07-17
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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