DEVICE CLASS
Class II
REGULATION
21 CFR 888.3060
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES
Recent clearances
K261031Signus Medinzintechnik GmbH · 510k2026-07-10
K253158Vy Spine, LLC · 510k2026-01-07
K241468Foundation Surgical Group, Inc. · 510k2024-11-07
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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