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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K896648
Device Name CONCEPT UNICOMPARTMENTAL KNEE SYSTEM
Applicant
Concept, Inc.
11311 Concept Blvd.
Largo,  FL  34643
Applicant Contact MARTHA C MILLER
Correspondent
Concept, Inc.
11311 Concept Blvd.
Largo,  FL  34643
Correspondent Contact MARTHA C MILLER
Regulation Number888.3520
Classification Product Code
HSX  
Date Received11/24/1989
Decision Date 06/05/1990
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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