DEVICE CLASS
Class II
REGULATION
21 CFR 888.3030
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
113
510(K)/PMA CLEARANCES
510k: 113
0
RECALL ENTRIES
Recent clearances
K262032TriMed, Inc. · 510k2026-07-16
K261191Newclip Technics · 510k2026-07-08
K261054Stryker Leibinger GmbH & Co KG · 510k2026-07-01
K261351Bonebridge AG · 510k2026-06-26
K260958I.T.S. GmbH · 510k2026-06-16
K261207Tyber Medical, LLC · 510k2026-06-12
K260761Medartis AG · 510k2026-06-05
K261002Biomet Microfixation · 510k2026-06-02
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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