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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K923583
Device Name ORTHOMET PERFECTA TOTAL HIP SYSTEM
Applicant
Orthomet, Inc.
6301 Cecilia Cir.
Minneapolis,  MN  55439
Applicant Contact DAVID CANNISTRACI
Correspondent
Orthomet, Inc.
6301 Cecilia Cir.
Minneapolis,  MN  55439
Correspondent Contact DAVID CANNISTRACI
Regulation Number888.3353
Classification Product Code
LZO  
Date Received07/20/1992
Decision Date 12/07/1992
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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