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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 K111716
Device Name KNOTLESS SUTURE FIXATION SYSTEM
Applicant
Core Essence Orthopaedics
575a Viriginia Dr.
Ft. Washington,  PA  19034
Applicant Contact JEFF MILLER
Correspondent
Core Essence Orthopaedics
575a Viriginia Dr.
Ft. Washington,  PA  19034
Correspondent Contact JEFF MILLER
Regulation Number888.3040
Classification Product Code
MBI  
Date Received06/20/2011
Decision Date 11/10/2011
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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