Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nlt Spine, Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
168 daysmedian FDA review time
269 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153665 | PROW FUSION-L | Nlt Spine, Ltd. | 2016-09-15 | 269 | 0 |
| K153786 | PROW FUSION-V | Nlt Spine, Ltd. | 2016-07-11 | 193 | 0 |
| K151654 | PROW FUSION | Nlt Spine, Ltd. | 2015-07-17 | 29 | 0 |
| K133061 | ESPIN SYSTEM | Nlt Spine, Ltd. | 2013-11-27 | 61 | 0 |
| K130254 | PROW FUSION | Nlt Spine, Ltd. | 2013-10-16 | 257 | 0 |
| K130057 | ESPIN | Nlt Spine, Ltd. | 2013-02-07 | 29 | 0 |
| K120553 | ESPIN | Nlt Spine, Ltd. | 2012-08-09 | 168 | 0 |
| K112359 | PROW FUSION | Nlt Spine, Ltd. | 2011-11-08 | 84 | 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