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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 K112965
Device Name NANO SUTURE ANCHOR
Applicant
LINVATEC CORPORATION D/B/A CONMED LINVATEC
11311 Concept Boulevard
LARGO,  FL  33773
Applicant Contact ASHLEA RICCI
Correspondent
LINVATEC CORPORATION D/B/A CONMED LINVATEC
11311 Concept Boulevard
LARGO,  FL  33773
Correspondent Contact ASHLEA RICCI
Regulation Number888.3040
Classification Product Code
MBI  
Date Received10/05/2011
Decision Date 11/02/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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