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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 K963255
Device Name PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT
Applicant
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
1450 E. BROOKS RD.
memphis,  TN  38116
Applicant Contact thomas l craig
Correspondent
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
1450 E. BROOKS RD.
memphis,  TN  38116
Correspondent Contact thomas l craig
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/19/1996
Decision Date 01/02/1997
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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