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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 K133224
Device Name Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES
Applicant
Conmed Corporation
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact NYROBIA FREEMAN
Correspondent
Conmed Corporation
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact NYROBIA FREEMAN
Regulation Number888.3040
Classification Product Code
MBI  
Date Received10/21/2013
Decision Date 01/03/2014
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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