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OSH — Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Class II

FDA Device Classification

FDA product code OSH covers "Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis", a Class II medical device regulated under 21 CFR 888.3070. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 19 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
OSH
Device Class
Class II
Regulation Number
888.3070
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K153446astura medicalOLYMPIC Posterior Spinal Fixation SystemApril 8, 2016
K140276medtronic sofamor danekCD HORIZON SPINAL SYSTEMMarch 13, 2014
K132574medicrea internationalPASS LP SPINAL SYSTEMNovember 8, 2013
K132303implanetIMPLANET SPINE SYSTEMOctober 10, 2013
K132575medicrea internationalPASS LP SPINAL SYSTEMOctober 3, 2013
K131802depuy spine, a johnson and johnsonEXPEDIUM, VIPER. VIPER 2 SPINE SYSTEMSeptember 12, 2013
K131615biomet spine (aka ebi, llc)POLARIS SPINAL SYSTEMSeptember 4, 2013
K131784k2mRANGE SPINAL SYSTEMAugust 30, 2013
K131321medtronic sofamor danek usaCD HORIZON SPINAL SYSTEMJune 5, 2013
K124058globus medicalCREO STABILIZATION SYSTEMMay 13, 2013
K131030k2mRANGE SPINAL SYSTEMMay 9, 2013
K122877k2mRANGE SPINAL SYSTEM, SMALL STATUREMay 8, 2013
K130655orthopediatricsRESPONSE SPINE SYSTEMMay 8, 2013
K130330k2mRANGE SPINAL SYSTEMMay 2, 2013
K123412k2mRANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTSFebruary 13, 2013
K123138medicrea internationalPASS LP SPINAL SYSTEMFebruary 5, 2013
K121630k2mRANGE SPINAL SYSTEMSeptember 11, 2012
K121250orthopediatricsOP SPINE SYSTEMJune 19, 2012
K120291orthopediatricsOP SPINE SYSTEMApril 16, 2012

FDA data resources