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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, fixation, bone
510(k) Number K142727
Device Name CrossCLIP Implant System
Applicant
OrthoDiscovery Group LLC(D.B.A. CrossRoads Extremity Systems
458 DISTRIBUTION PKWY
COLLIERVILLE,  TN  38017
Applicant Contact Vernon Hartdegen
Correspondent
OrthoDiscovery Group LLC(D.B.A. CrossRoads Extremity Systems
458 DISTRIBUTION PKWY
COLLIERVILLE,  TN  38017
Correspondent Contact Vernon Hartdegen
Regulation Number888.3030
Classification Product Code
JDR  
Date Received09/23/2014
Decision Date 10/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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