← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
DEVICE CLASS
Class II
REGULATION
21 CFR 888.3353
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
23
510(K)/PMA CLEARANCES
510k: 23
0
RECALL ENTRIES
Recent clearances
K261009Waldemar Link GmbH & Co. KG · 510k2026-07-06
K260831Zimmer, Inc. · 510k2026-06-16
K260182Zimmer, Inc. · 510k2026-04-27
K260037Implantcast GmbH · 510k2026-03-30
K252401Implantcast GmbH · 510k2026-03-12
K253171Maxx Orthopedics, Inc. · 510k2026-01-15
K250450Medacta International S.A. · 510k2025-09-19
K243021Signature Orthopaedics Pty, Ltd. · 510k2025-08-07
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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