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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 BOULEVARD
LARGO,  FL  33773 -4908
Applicant Contact JOHN CUSACK
Correspondent
CONMED LINVATEC
11311 CONCEPT BOULEVARD
LARGO,  FL  33773 -4908
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
Recalls CDRH Recalls
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