Safe Orthopaedics
Medical device manufacturer in Chicago, IL.
13510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K201648 | Sterispine PSNKB · Traditional | 07/30/2020SE |
| K170528 | Sterispine PSNKB · Special | 03/09/2017SE |
| K162531 | Sterispine CCOVE · Traditional | 12/29/2016SE |
| K151921 | Sterispine PSNKB · Traditional | 10/08/2015SE |
| K151747 | Sterispine PSNKB · Traditional | 10/05/2015SE |
| K151756 | Sterispine LC CageMAX · Traditional | 08/21/2015SE |
| K150092 | STERISPINE PS Pedicle ScrewNKB · Special | 02/10/2015SE |
| K140802 | Sterispine PSNKB · Special | 06/04/2014SE |
| K133893 | Sterispine LC CageMAX · Abbreviated | 03/14/2014SE |
| K130632 | Sterispine PS Pedicle ScrewNKB · Special | 05/03/2013SE |
| K122021 | Sterispine LC CageMAX · Abbreviated | 09/20/2012SE |
| K121299 | Sterispineps Pedicle Screw, Sterispineps RodNKB · Traditional | 07/30/2012SE |
| K112453 | Sterispineps Pedicle ScrewNKB · Abbreviated | 11/15/2011SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1572-2022 Class II | SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers…The type of screw printed on the traceability record for the patient label is incorrect, but the type of… | 06/03/2022Completed |