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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 K150768
Device Name JuggerKnot Soft Anchors
Applicant
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE PO BOX 587
WARSAW,  IL  46581
Applicant Contact ADAM CARGILL
Correspondent
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE PO BOX 587
WARSAW,  IL  46581
Correspondent Contact ADAM CARGILL
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/24/2015
Decision Date 09/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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