Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
N Spine, Inc. · 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) |
|---|---|---|---|---|---|
| K072685 | NGARDE SYSTEM | N Spine, Inc. | 2007-10-19 | 28 | 9 |
| K061774 | NFIX II PEDICLE SCREW SYSTEM | N Spine, Inc. | 2006-12-13 | 173 | 7 |
| K053623 | NFIX FUSION SYSTEM | N-Spine, Inc. | 2006-07-12 | 196 | 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