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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 K131035
Device Name Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
Applicant
LINVATEC CORPORATION D/B/A CONMED LINVATEC
11311 Concept Boulevard
LARGO,  FL  33773
Applicant Contact JOY LOVETT
Correspondent
LINVATEC CORPORATION D/B/A CONMED LINVATEC
11311 Concept Boulevard
LARGO,  FL  33773
Correspondent Contact JOY LOVETT
Regulation Number888.3040
Classification Product Code
MBI  
Date Received04/12/2013
Decision Date 07/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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