510(k) K180503 ยท HSB Rod, Fixation, Intramedullary And Accessories
PRECICE STRYDE System
| Applicant | Nuvasive Specialized Orthopedics, Inc., Alisa Viejo CA, US |
| Decision | Substantially Equivalent, Apr 3, 2018 |
| Received | Feb 26, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180503
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2021 | Nuvasive Specialized Orthopedics Inc PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. Open, Classified |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.