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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 Boulevard
Austin,  TX  78758
Applicant Contact Michael A Siano
Correspondent
Encore Medical, L.P. dba DJO Surgical
9800 Metric Boulevard
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
Recalls CDRH Recalls
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