Nlt Spine, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Nlt Spine, Ltd.” (first 2011, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 126 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 168 |
| 2013 | 3 | 61 |
| 2014 | 0 | — |
| 2015 | 1 | 29 |
| 2016 | 2 | 231 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 | 5 |
| HRX | Arthroscope | 3 | 3 |
Review panels
- Orthopedic (8)
Most recent Nlt Spine, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153665 | PROW FUSION-L | MAX | 2016-09-15 | 269 |
| K153786 | PROW FUSION-V | MAX | 2016-07-11 | 193 |
| K151654 | PROW FUSION | MAX | 2015-07-17 | 29 |
| K133061 | ESPIN SYSTEM | HRX | 2013-11-27 | 61 |
| K130254 | PROW FUSION | MAX | 2013-10-16 | 257 |
| K130057 | ESPIN | HRX | 2013-02-07 | 29 |
| K120553 | ESPIN | HRX | 2012-08-09 | 168 |
| K112359 | PROW FUSION | MAX | 2011-11-08 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Nlt Spine, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nlt Spine, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Nlt Spine, Ltd.” (first 2011, latest 2016), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nlt Spine, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nlt Spine, Ltd. is 126 days.
Which FDA product codes appear under Nlt Spine, Ltd.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 5); HRX (Arthroscope, 3).
Next steps
- See all 8 Nlt Spine, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Nlt Spine, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.