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FDA Product Code

FDA Product Code OIY — Clearance Directory

Device Class
Class II
Assigned Panel
Orthopedic
21 CFR Citation
888.3560

510(k) Clearances — 12 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K252887 DePuy ATTUNE™ Knee System DePuy Orthopaedics, Inc. 2026-05-22 Traditional PDF ↗
K242665 DePuy ATTUNE™ Total Knee System Depuy Orthopedics, Inc. 2024-11-01 Traditional PDF ↗
K201347 DePuy ATTUNE™ Total Knee System DePuy Orthopaedics, Inc. 2020-06-18 Special PDF ↗
K120038 A200 KNEE SYSTEM Renovis Surgical Technologies, LLC 2013-02-14 Traditional PDF ↗
K121727 MOVATION KNEE SYSTEM Encore Medical L.P. 2012-08-15 Special PDF ↗
K113756 HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA Encore Medical L.P. 2012-03-14 Special PDF ↗
K111433 DEPUY STTUNE (TM) PS KNEE SYSTEM DePuy Orthopaedics, Inc. 2011-08-30 Traditional PDF ↗
K103756 DEPUY ATTUNE TOTAL KNEE SYSTEM DePuy Orthopaedics, Inc. 2011-03-15 Traditional PDF ↗
K103223 HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS Encore Medical L.P. 2010-12-21 Traditional PDF ↗
K101433 DEPUY ATTUNE KNEE SYSTEM DePuy Orthopaedics, Inc. 2010-12-10 Traditional PDF ↗
K091956 HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 Encore Medical L.P. 2010-09-28 Traditional PDF ↗
K100048 E1 ANTIOXIDANT INFUSED TECHNOLOGY Biomet Manufacturing Corp 2010-03-09 Traditional PDF ↗

Product code OIY · Class II · Orthopedic. Data: openFDA.