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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe, Constrained, Polymer
510(k) Number K946236
Device Name PROFIX CONFORMING PLUS TIBIAL INSERT
Applicant
Smith & Nephew Richards, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Applicant Contact THOMAS L CRAIG
Correspondent
Smith & Nephew Richards, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Correspondent Contact THOMAS L CRAIG
Regulation Number888.3720
Classification Product Code
KWH  
Date Received12/22/1994
Decision Date 07/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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