Phygen, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Phygen, LLC” (first 2011, latest 2012), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 69 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 | 2 | 46 |
| 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 6 | 6 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Phygen, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120355 | LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM | NKB | 2012-03-07 | 30 |
| K113366 | LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM | NKB | 2012-01-17 | 63 |
| K112931 | LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM | NKB | 2011-11-02 | 30 |
| K110679 | DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM | NKB | 2011-08-02 | 145 |
| K110588 | LEUCADIA PEDICLE SCREW SYSTEM | NKB | 2011-05-25 | 84 |
| K103748 | LAGUNA PEDICLE SCREW SYSTEM | NKB | 2011-03-02 | 69 |
| K103102 | LEUCADIA PEDICLE SCREW SYSTEM | MNI | 2011-02-08 | 111 |
Recalls
openFDA lists no recalls under a recalling firm named Phygen, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Phygen, LLC?
FDA lists 7 510(k) clearances under the applicant name “Phygen, LLC” (first 2011, latest 2012), 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 Phygen, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Phygen, LLC is 69 days.
Which FDA product codes appear under Phygen, LLC?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 6); MNI (Orthosis, Spinal Pedicle Fixation, 1).
Next steps
- See all 7 Phygen, LLC clearances with predicates and recalls
- Run predicate analysis for product code NKB, Phygen, 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.