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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Fixation Cerclage, Sublaminar
510(k) Number K161267
Device Name Response BandLoc Spinal Fixation
Applicant
OrthoPediatrics Corp.
2850 Frontier Dr.
Warsaw,  IN  46538
Applicant Contact MARK FOX
Correspondent
OrthoPediatrics Corp.
2850 Frontier Dr.
Warsaw,  IN  46538
Correspondent Contact MARK FOX
Regulation Number888.3010
Classification Product Code
OWI  
Date Received05/05/2016
Decision Date 08/11/2016
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
Recalls CDRH Recalls
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