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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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K942891
Device Name SUMMIT TOTAL HIP SYSTEM
Applicant
Kirschner Medical Corp.
20-01 Pollitt Dr.
Fair Lawn,  NJ  07410
Applicant Contact JACQUELYN A HUGHES
Correspondent
Kirschner Medical Corp.
20-01 Pollitt Dr.
Fair Lawn,  NJ  07410
Correspondent Contact JACQUELYN A HUGHES
Regulation Number888.3353
Classification Product Code
MEH  
Date Received06/20/1994
Decision Date 11/02/1994
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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