Panels › Orthopedic › Product code OSH · Class 2
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Regulation 888.3070
0510(k)s in 12 months (19 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OSH
| Company | 510(k)s | Recalls |
|---|---|---|
| K2m, Inc. | 6 | 0 |
| OrthoPediatrics Corp. | 3 | 1 |
| Medicrea International | 3 | 0 |
| Medtronic Sofamor Danek | 2 | 0 |
| Astura Medical | 1 | 0 |
| Biomet Spine (Aka Ebi, LLC) | 1 | 0 |
| Depuy Spine, A Johnson & Johnson Company | 1 | 0 |
| Globus Medical, Inc. | 1 | 0 |
| Implanet, S.A. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2017 | OrthoPediatrics Corp Response 5.5/6.0 Spine System 7.0mm x 40mm
Pedicle Screw
Product Usage:
Posterior non-cervical pedicle screw fixation Terminated |
OSH | K150600 |
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