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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
510(k) Number K931423
Device Name PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM
Applicant
Orthomed
256 Rue Des Vignes Dardelain
Marsannay-La-Cote,  FR 21160
Applicant Contact DAVID A CANNISTRACI
Correspondent
Orthomed
256 Rue Des Vignes Dardelain
Marsannay-La-Cote,  FR 21160
Correspondent Contact DAVID A CANNISTRACI
Regulation Number888.3360
Classification Product Code
LWJ  
Date Received03/22/1993
Decision Date 10/13/1994
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
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