← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
DEVICE CLASS
Class II
REGULATION
21 CFR 888.3353
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES
Recent clearances
K250375Waldemar Link GmbH & Co. KG · 510k2025-11-05
K251166Medacta International S.A. · 510k2025-06-13
K251052Ortho Development Corp. · 510k2025-05-22
K242315United Orthopedic Corporation · 510k2025-05-01
K243839Exactech, Inc. · 510k2025-03-10
K243162Signature Orthopaedics Pty, Ltd. · 510k2024-11-25
K241472Corin U.S.A. Limited · 510k2024-10-03
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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