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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K212941
Device Name Porous Patella
Applicant
Encore Medical, L.P. Dba Djo Surgical
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact Michael A Siano
Correspondent
Encore Medical, L.P. Dba Djo Surgical
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact Michael A Siano
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received09/15/2021
Decision Date 01/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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