Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Nuvasive Specialized Orthopedics, Inc. · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
256 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230765 | Precice Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. | 2023-08-29 | 162 | 0 |
| K220234 | Precice Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2023-03-15 | 412 | 0 |
| K202348 | External Remote Controller ERC 4P | Nuvasive Specialized Orthopedics, Inc. | 2020-12-22 | 126 | 0 |
| K200430 | Precice® Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. | 2020-09-16 | 208 | 0 |
| K201567 | Precice® Bone Transport System | Nuvasive Specialized Orthopedics, Inc. | 2020-08-10 | 60 | 1 |
| K201543 | MAGEC® System | Nuvasive Specialized Orthopedics, Inc. | 2020-07-30 | 51 | 1 |
| K193016 | PRECICE Bone Transport System | Nuvasive Specialized Orthopedics, Inc. | 2020-05-08 | 192 | 0 |
| K193617 | Precice® Screws | Nuvasive Specialized Orthopedics, Inc. | 2020-05-08 | 134 | 0 |
| K192181 | PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | 2019-11-07 | 87 | 1 |
| K191336 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | 2019-09-26 | 132 | 0 |
| K182170 | PRECICE® BONE TRANSPORT™ System | Nuvasive Specialized Orthopedics, Inc. | 2019-02-05 | 179 | 1 |
| K180503 | PRECICE STRYDE System | Nuvasive Specialized Orthopedics, Inc. | 2018-04-03 | 36 | 1 |
| K173129 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | 2017-12-01 | 63 | 0 |
| K172628 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | 2017-09-25 | 24 | 0 |
| K172061 | PRECICE UNYTE System | Nuvasive Specialized Orthopedics, Inc. | 2017-08-24 | 48 | 0 |
| K170169 | PRECICE Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2017-06-09 | 141 | 0 |
| K162927 | PRECICE UNYTE CoCr System | Nuvasive Specialized Orthopedics, Inc. | 2017-04-06 | 169 | 0 |
| K170346 | PRECICE Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2017-03-07 | 33 | 0 |
| K160352 | MAGEC® Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Inc. | 2016-10-21 | 256 | 0 |
| K161751 | MAGEC® Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Inc. | 2016-09-02 | 70 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda