Safe Orthopaedics
Eragny Sur Oise, FR
Safe Orthopaedics appears in FDA device records in Eragny Sur Oise, FR. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Safe Orthopaedics between 2011 and 2020. The busiest year on record is 2015, with 4. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 4 |
| 2016 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201648 | Sterispine™ PS | NKB | Substantially Equivalent | |
| K170528 | Sterispine™ PS | NKB | Substantially Equivalent | |
| K162531 | STERISPINE CC | OVE | Substantially Equivalent | |
| K151921 | STERISPINE PS | NKB | Substantially Equivalent | |
| K151747 | STERISPINE PS | NKB | Substantially Equivalent | |
| K151756 | STERISPINE LC CAGE | MAX | Substantially Equivalent | |
| K150092 | STERISPINE PS Pedicle Screw | NKB | Substantially Equivalent | |
| K140802 | STERISPINE PS | NKB | Substantially Equivalent | |
| K133893 | STERISPINE LC CAGE | MAX | Substantially Equivalent | |
| K130632 | STERISPINE PS PEDICLE SCREW | NKB | Substantially Equivalent | |
| K122021 | STERISPINE LC CAGE | MAX | Substantially Equivalent | |
| K121299 | STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD | NKB | Substantially Equivalent | |
| K112453 | STERISPINEPS PEDICLE SCREW | NKB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1572-2022 | SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740. | The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct. | Class II | Completed |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain