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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 K090186
Device Name CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES
Applicant
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact JOY LOVETT
Correspondent
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact JOY LOVETT
Regulation Number888.3030
Classification Product Code
MAI  
Date Received01/26/2009
Decision Date 04/10/2009
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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