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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K072291
Device Name CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR
Applicant
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact JON WARD
Correspondent
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact JON WARD
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
JDR   MAI  
Date Received08/16/2007
Decision Date 07/14/2008
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
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