510(k) K201648 · NKB Thoracolumbosacral Pedicle Screw System
Sterispine PS
| Applicant | Safe Orthopaedics, Eragny Sur Oise, FR |
| Decision | Substantially Equivalent, Jul 30, 2020 |
| Received | Jun 18, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201648
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2022 | SAFE ORTHOPAEDICS LLC SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers
KITM640, KITM645, and KITM740. Completed |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.