SAFE ORTHOPAEDICS LLC
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1572-2022 | Class II | SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, | June 3, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K201648 | Sterispine PS | July 30, 2020 |
| K170528 | Sterispine PS | March 9, 2017 |
| K162531 | STERISPINE CC | December 29, 2016 |
| K151921 | STERISPINE PS | October 8, 2015 |
| K151747 | STERISPINE PS | October 5, 2015 |
| K151756 | STERISPINE LC CAGE | August 21, 2015 |
| K150092 | STERISPINE PS Pedicle Screw | February 10, 2015 |
| K140802 | STERISPINE PS | June 4, 2014 |
| K133893 | STERISPINE LC CAGE | March 14, 2014 |
| K130632 | STERISPINE PS PEDICLE SCREW | May 3, 2013 |
| K122021 | STERISPINE LC CAGE | September 20, 2012 |
| K121299 | STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD | July 30, 2012 |
| K112453 | STERISPINEPS PEDICLE SCREW | November 15, 2011 |