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510(k) K121630

RANGE SPINAL SYSTEM by K2m, Inc. — Product Code OSH

Clearance Details

Decision
SESU ()
Decision Date
September 11, 2012
Date Received
June 4, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.

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Other clearances for product code OSH

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