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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 K200097
Device Name Response BandLoc Spinal Fixation
Applicant
OrthoPediatrics Corp.
2850 Frontier Dr.
Warsaw,  IN  46582
Applicant Contact Jackie Jaskula
Correspondent
OrthoPediatrics Corp.
2850 Frontier Dr.
Warsaw,  IN  46582
Correspondent Contact Jackie Jaskula
Regulation Number888.3010
Classification Product Code
OWI  
Date Received01/16/2020
Decision Date 03/16/2020
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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