DEVICE CLASS
Class II
REGULATION
21 CFR 890.5880
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
PM
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES
Recent clearances
K250266Ceragem Co., Ltd. · 510k2025-07-11
K241193Marzzan Lucas Jorge · 510k2025-01-31
K243644Ceragem Co., Ltd. · 510k2025-01-08
K243355Ceragem Co., Ltd. · 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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