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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, Cemented
510(k) Number K922733
Device Name PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP
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 Number888.3350
Classification Product Code
JDI  
Date Received06/08/1992
Decision Date 02/09/1993
Decision Substantially Equivalent (SESE)
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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