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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pedicle screw spinal system, adolescent idiopathic scoliosis
510(k) Number K120291
Device Name OP SPINE SYSTEM
Original Applicant
ORTHOPEDIATRICS, CORP.
2850 frontier drive
warsaw,  IN  46582
Original Contact mark fox
Regulation Number888.3070
Classification Product Code
OSH  
Subsequent Product Code
KWP  
Date Received01/31/2012
Decision Date 04/16/2012
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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