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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K101100
Device Name CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503
Applicant
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact JOHN CUSACK
Correspondent
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact JOHN CUSACK
Regulation Number888.3030
Classification Product Code
MAI  
Date Received04/20/2010
Decision Date 08/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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