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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K932246
Device Name FOUNDATION METAL-BACKED PATELLA
Applicant
Encore Orthopedics, Inc.
8920 Business Park Dr.
Sutie 380
Austin,  TX  78759
Applicant Contact WEBB
Correspondent
Encore Orthopedics, Inc.
8920 Business Park Dr.
Sutie 380
Austin,  TX  78759
Correspondent Contact WEBB
Regulation Number888.3560
Classification Product Code
JWH  
Date Received05/10/1993
Decision Date 07/22/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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