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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 K900619
Device Name CAAS UNICOMPARMENTAL KNEE SYSTEM
Applicant
Techmedica, Inc.
1380 Flynn Rd.
Camarillo,  CA  93010
Applicant Contact GREGORY C ROSE
Correspondent
Techmedica, Inc.
1380 Flynn Rd.
Camarillo,  CA  93010
Correspondent Contact GREGORY C ROSE
Regulation Number888.3520
Classification Product Code
HSX  
Date Received02/08/1990
Decision Date 06/11/1990
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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