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Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

FDA product code OSH · Class 2 · Orthopedic

58,373
Registered devices
108
Adverse events
1
Recalls
19
510(k) clearances

Devices with this code

CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.Nex-D2 — NEXT ORTHOSURGICAL, INC.Arsenal — ALPHATEC SPINE, INC.XIA 3 — Stryker CorporationCREO — GLOBUS MEDICAL, INC.Reform Ti Modular — PRECISION SPINE, INC.VIPER — Medos International SàrlReLine — Nuvasive, Inc.ReLine — Nuvasive, Inc.APEX-DL Spine System — SPINECRAFT, LLCCREO — GLOBUS MEDICAL, INC.CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.Canaveral® — FLOSPINE LLCReLine — Nuvasive, Inc.ReLine — Nuvasive, Inc.ReLine — Nuvasive, Inc.IMPLANET SPINE SYSTEM — IMPLANETXIA 4 5 — Stryker CorporationNex-D2 — NEXT ORTHOSURGICAL, INC.Arsenal Deformity Spinal Fixation System — ALPHATEC SPINE, INC.APEX-DL Spine System — SPINECRAFT, LLCVitality® — BIOMET SPINE LLCVitality® — BIOMET SPINE LLCDENALI® MI Spinal System — VB Spine LLC

Recent recalls

DateFirmReason
2017-08-03OrthoPediatrics CorpThe 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.