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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 K973672
Device Name FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA
Applicant
ENCORE ORTHOPEDICS, INC.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Applicant Contact DEBBIE DE LOS SANTOS
Correspondent
ENCORE ORTHOPEDICS, INC.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Correspondent Contact DEBBIE DE LOS SANTOS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/26/1997
Decision Date 12/18/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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