OSH

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Product code

OSH

Device name

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Device class

Class 2

21 CFR

21 CFR 888.3070

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

19 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).