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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K932024
Device Name CCG CERCLAGE SYSTEM
Applicant
Encore Orthopedics, Inc.
8920 Business Park Dr.
Sutie 380
Austin,  TX  78759
Applicant Contact WEBB
Correspondent
Encore Orthopedics, Inc.
8920 Business Park Dr.
Sutie 380
Austin,  TX  78759
Correspondent Contact WEBB
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received04/26/1993
Decision Date 02/14/1995
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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