510(k) K192181 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
PRECICE Plating System
| Applicant | Nuvasive Specialized Orthopedics, Inc., Alisa Viejo CA, US |
| Decision | Substantially Equivalent, Nov 7, 2019 |
| Received | Aug 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192181
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2021 | Nuvasive Specialized Orthopedics Inc PRECICE PLATE - 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.