OSH · Class II · 21 CFR 888.3070

FDA Product Code OSH: Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Intended To Stabilize The Thoracolumbar Spine As An Adjunct To Fusion Using Allograft And/or Autograft To Treat Adolescent Idiopathic Scoliosis.

Leading manufacturers include K2m, Inc., OrthoPediatrics Corp. and Globus Medical, Inc..

19
Total
19
Cleared
86d
Avg days
2012
Since

FDA 510(k) Cleared Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Devices (Product Code OSH)

19 devices
1–19 of 19
Cleared Mar 13, 2014
CD HORIZON SPINAL SYSTEM
K140276
Medtronic Sofamor Danek
Orthopedic · 38d
Cleared Aug 30, 2013
RANGE SPINAL SYSTEM
K131784
K2m, Inc.
Orthopedic · 73d
Cleared May 13, 2013
CREO STABILIZATION SYSTEM
K124058
Globus Medical, Inc.
Orthopedic · 133d
Cleared May 09, 2013
RANGE SPINAL SYSTEM
K131030
K2m, Inc.
Orthopedic · 27d
Cleared May 08, 2013
RANGE SPINAL SYSTEM, SMALL STATURE
K122877
K2m, Inc.
Orthopedic · 231d
Cleared May 08, 2013
RESPONSE SPINE SYSTEM
K130655
OrthoPediatrics Corp.
Orthopedic · 57d
Cleared May 02, 2013
RANGE SPINAL SYSTEM
K130330
K2m, Inc.
Orthopedic · 80d
Cleared Feb 13, 2013
RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
K123412
K2m, Inc.
Orthopedic · 99d
Cleared Sep 11, 2012
RANGE SPINAL SYSTEM
K121630
K2m, Inc.
Orthopedic · 99d
Cleared Jun 19, 2012
OP SPINE SYSTEM
K121250
OrthoPediatrics Corp.
Orthopedic · 55d
Cleared Apr 16, 2012
OP SPINE SYSTEM
K120291
OrthoPediatrics Corp.
Orthopedic · 76d

About Product Code OSH - Regulatory Context