OSHClass II

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

21 CFR 888.3070 / Orthopedic

OSH is the FDA product code for Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis, a class II device type, regulated under 21 CFR 888.3070. FDA's definition for this code reads: "Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis". As of 2026-09-10, FDA records hold 19 510(k) clearances under this code, the most recent dated 2016-04-08, and one recall.

Classification record

Product code: OSH
Device name: Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
FDA definition: Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
Regulation: 21 CFR 888.3070
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 19
Ingested recalls: 1

Clearances, product code OSH

By decision year

19 clearances under product code OSH with a decision year between 2012 and 2016, 2013 the highest year at 14.

Show the numbers

510(k) clearances under FDA product code OSH by decision year
Year	Clearances
2012	3
2013	14
2014	1
2016	1

Applicants with the most clearances

Product code OSH

Applicants holding the most 510(k) clearances under product code OSH
Applicant	Clearances
K2M, Inc	6
Medicrea International	3
Orthopediatrics Corp	3
Astura Medical	1
Biomet Spine (Aka Ebi, LLC)	1
Depuy Spine, A Johnson & Johnson Company	1
Globus Medical, Inc.	1
Implanet	1
Medtronic Sofamor Danek	1
Medtronic Sofamor Danek USA Inc	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 142 companies shown, in name order