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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K150600
Device Name Response 5.5/6.0 Spine System
Applicant
ORTHOPEDIATRICS CORP.
2850 FRONTIER DRIVE
warsaw,  IL  46582
Applicant Contact mark fox
Correspondent
ORTHOPEDIATRICS CORP.
2850 Frontier Drive
warsaw,  IN  46582
Correspondent Contact mark fox
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI   OSH  
Date Received03/10/2015
Decision Date 05/22/2015
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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