DEVICE CLASS
Class II
REGULATION
21 CFR 888.3027
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES
Recent clearances
K251896Xelite Biomed , Ltd. · 510k2026-01-28
K250637Amber Implants · 510k2025-05-30
K243537Xelite Biomed , Ltd. · 510k2025-04-11
K241775Xelite Biomed , Ltd. · 510k2024-09-18
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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