Signus Medical, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Signus Medical, LLC” (first 2002, latest 2009), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Signus Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091122 | DIANA FUSION CAGE | MAX | 2009-09-18 | 154 |
| K092073 | MONOPOLY PEDICLE SCREW SYSTEM | NKB | 2009-08-07 | 30 |
| K081108 | MONOPOLY PEDICLE SCREW SYSTEM | NKB | 2008-07-14 | 87 |
| K052096 | NUBIC SPINAL IMPLANT | MQP | 2005-08-16 | 13 |
| K031455 | CONKLUSION PEDICLE SCREW SYSTEM | MNI | 2003-10-22 | 168 |
| K031757 | PEEK TETRIS SPINAL IMPLANT | MQP | 2003-07-30 | 54 |
| K022793 | TETRIS SPINAL IMPLANT | MQP | 2003-04-08 | 228 |
| K020836 | RABEA CEMENT RESTRICTOR | JDK | 2002-06-11 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Signus Medical, LLC.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Signus Medizintechnik GmbH (24 510(k)s)
- Signus Medinzintechnik GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Signus Medical, LLC?
FDA lists 8 510(k) clearances under the applicant name “Signus Medical, LLC” (first 2002, latest 2009), across 5 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 Signus Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Signus Medical, LLC is 88 days.
Which FDA product codes appear under Signus Medical, LLC?
The most frequent FDA product codes under this applicant name are MQP (Spinal Vertebral Body Replacement Device, 3); NKB (Thoracolumbosacral Pedicle Screw System, 2); JDK (Prosthesis, Hip, Cement Restrictor, 1).
Next steps
- See all 8 Signus Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code MQP, Signus Medical, LLC'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.