510(k) K201567 · HSB Rod, Fixation, Intramedullary And Accessories
Precice® Bone Transport System
| Applicant | Nuvasive Specialized Orthopedics, Inc., Alisa Viejo CA, US |
| Decision | Substantially Equivalent, Aug 10, 2020 |
| Received | Jun 11, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201567
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2021 | Nuvasive Specialized Orthopedics Inc Precice Bone Transport - 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 |
| Jul 24, 2020 | Nuvasive Specialized Orthopedics Inc NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend
Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screw Open, Classified |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.