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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 K912663
Device Name NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT
Applicant
INTERMEDICS ORTHOPEDICS
1300 EAST ANDERSON LN.
BUILDING C
austin,  TX  78752
Applicant Contact webb
Correspondent
INTERMEDICS ORTHOPEDICS
1300 EAST ANDERSON LN.
BUILDING C
austin,  TX  78752
Correspondent Contact webb
Regulation Number888.3560
Classification Product Code
JWH  
Date Received06/18/1991
Decision Date 09/16/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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