FDA product code OSH: Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
OSH is the FDA product code for pedicle screw spinal system, adolescent idiopathic scoliosis. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel. FDA has cleared 19 510(k) submissions under OSH, from 10 different applicants. The average 510(k) review took 86 days (median 80). FDA has posted 1 recall for OSH devices.
Definition
Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
Classification
| Field | Value |
|---|---|
| Device name | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class II |
| Regulation | 21 CFR 888.3070 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every OSH clearance
Top OSH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| K2m, Inc. | 6 | 2013-08-30 |
| Medicrea International | 3 | 2013-11-08 |
| OrthoPediatrics Corp. | 3 | 2013-05-08 |
| Astura Medical | 1 | 2016-04-08 |
| Medtronic Sofamor Danek | 1 | 2014-03-13 |
5 more applicants have OSH clearances. See the full list in Caduvo.
Most recent OSH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153446 | Astura Medical | OLYMPIC Posterior Spinal Fixation System | 2016-04-08 | 133 |
| K140276 | Medtronic Sofamor Danek | CD HORIZON SPINAL SYSTEM | 2014-03-13 | 38 |
| K132574 | Medicrea International | PASS LP SPINAL SYSTEM | 2013-11-08 | 84 |
| K132303 | Implanet, S.A. | IMPLANET SPINE SYSTEM | 2013-10-10 | 78 |
| K132575 | Medicrea International | PASS LP SPINAL SYSTEM | 2013-10-03 | 48 |
Recalls for OSH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-08-03.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code OSH?
OSH is the FDA product code for pedicle screw spinal system, adolescent idiopathic scoliosis. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel.
What device class is OSH?
Class II, regulation 21 CFR 888.3070. Typical premarket route: 510(k).
How long does a 510(k) take for product code OSH?
Across 19 cleared submissions the average was 86 days from receipt to decision (median 80).
Which companies have the most OSH clearances?
K2m, Inc. (6); Medicrea International (3); OrthoPediatrics Corp. (3); Astura Medical (1); Medtronic Sofamor Danek (1).
Have OSH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-08-03.
Next steps
- Run an FDA pathway report with predicate devices for product code OSH
- Run a recall and safety report across every OSH manufacturer
- Watch product code OSH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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