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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, Nondegradable, Soft Tissue
510(k) Number K073481
Device Name THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES
Applicant
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact JOY LOVETT
Correspondent
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact JOY LOVETT
Regulation Number888.3040
Classification Product Code
MBI  
Date Received12/11/2007
Decision Date 01/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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