Neoligaments, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Neoligaments, Ltd.” (first 1990, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 86 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | 4 | 4 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 2 | 2 |
| HTW | Bit, Drill | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Neoligaments, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941772 | CRADLE FIXATION DEVICE | JDR | 1995-08-07 | 483 |
| K952543 | GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET | HWE | 1995-06-22 | 35 |
| K935753 | THE GRAFTOLOGER | HWE | 1994-04-25 | 150 |
| K930339 | REAMER BIT | HTW | 1993-08-06 | 193 |
| K913461 | FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM | JDR | 1991-10-15 | 71 |
| K911445 | FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM | JDR | 1991-06-28 | 86 |
| K904340 | FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM | JDR | 1990-10-19 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Neoligaments, 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 Neoligaments, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Neoligaments, Ltd.” (first 1990, latest 1995), across 3 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 Neoligaments, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neoligaments, Ltd. is 86 days.
Which FDA product codes appear under Neoligaments, Ltd.?
The most frequent FDA product codes under this applicant name are JDR (Staple, Fixation, Bone, 4); HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, 2); HTW (Bit, Drill, 1).
Next steps
- See all 7 Neoligaments, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JDR, Neoligaments, 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.