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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 K121250
Device Name OP SPINE SYSTEM
Applicant
ORTHOPEDIATRICS, CORP.
2850 FRONTIER DRIVE
WARSAW,  IN  46582
Applicant Contact MARK FOX
Correspondent
ORTHOPEDIATRICS, CORP.
2850 FRONTIER DRIVE
WARSAW,  IN  46582
Correspondent Contact MARK FOX
Regulation Number888.3070
Classification Product Code
OSH  
Subsequent Product Code
KWP  
Date Received04/25/2012
Decision Date 06/19/2012
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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