Product code OSH— Orthopedic
RANGE SPINAL SYSTEM
- Classification name
- Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Total cleared
- 19
- First cleared
- Most recent
FDA classification definition
“Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.”
Market context for product code OSH
FDA has cleared devices under product code OSH between 2012 and 2016, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2016
- 2014
- 2013
- 2012
Top applicants under product code OSH
Recent clearances under product code OSH
- K153446 — OLYMPIC Posterior Spinal Fixation System
- K140276 — CD HORIZON SPINAL SYSTEM
- K132574 — PASS LP SPINAL SYSTEM
- K132303 — IMPLANET SPINE SYSTEM
- K132575 — PASS LP SPINAL SYSTEM
- K131802 — EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
- K131615 — POLARIS SPINAL SYSTEM
- K131784 — RANGE SPINAL SYSTEM
- K131321 — CD HORIZON SPINAL SYSTEM
- K124058 — CREO STABILIZATION SYSTEM
- K131030 — RANGE SPINAL SYSTEM
- K122877 — RANGE SPINAL SYSTEM, SMALL STATURE
- K130655 — RESPONSE SPINE SYSTEM
- K130330 — RANGE SPINAL SYSTEM
- K123412 — RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
- K123138 — PASS LP SPINAL SYSTEM
- K121630 — RANGE SPINAL SYSTEM
- K121250 — OP SPINE SYSTEM
- K120291 — OP SPINE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.