Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Novaspine, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062456 | NOVASPINE POWERED SUCTION PUMP PRO-1 | Novaspine, LLC | 2006-10-16 | 54 | 0 |
| K061133 | SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND | Novaspine, LLC | 2006-07-11 | 78 | 0 |
| K051607 | NOVASPINE CEMENT RESTRICTOR NSCR | Novaspine, LLC | 2005-10-07 | 112 | 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