Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Choicespine · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine | 2019-02-22 | 63 | 0 |
| K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) Syste | Choicespine | 2017-09-15 | 100 | 0 |
| K171456 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Scr | Choicespine | 2017-08-03 | 78 | 0 |
| K132049 | THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS | Choicespine | 2014-08-15 | 409 | 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