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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 K071520
Device Name RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X
Applicant
Core Essence Orthopaedics, LLC
301 Oxford Valley Rd.
Suite 905b
Yardley,  PA  19067
Applicant Contact SHAWN T HUXEL
Correspondent
Core Essence Orthopaedics, LLC
301 Oxford Valley Rd.
Suite 905b
Yardley,  PA  19067
Correspondent Contact SHAWN T HUXEL
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Codes
HWC   JDR  
Date Received06/04/2007
Decision Date 08/10/2007
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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