Neoligaments, Ltd.: FDA clearances and approvals
Neoligaments, Ltd. has 7 FDA 510(k) clearances (first 1990, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time: 86 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Neoligaments, Ltd. have?
Neoligaments, Ltd. has 7 FDA 510(k) clearances (first 1990, latest 1995), across 3 product codes in 1 review panel.
How long does FDA take to clear Neoligaments, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Neoligaments, Ltd.'s cleared 510(k)s is 86 days.
What devices does Neoligaments, Ltd. make?
Its most frequent FDA product codes are JDR (Staple, Fixation, Bone, 4); HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, 2); HTW (Bit, Drill, 1).
Has Neoligaments, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Neoligaments, Ltd. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.