← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
DEVICE CLASS
Class II
REGULATION
21 CFR 888.3670
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
K253592Zimmer, Inc. · 510k2026-04-13
K251098Zimmer, Inc. · 510k2025-08-11
K250848Zimmer, Inc. · 510k2025-07-02
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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