Dfine, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Dfine, Inc.” (first 2006, latest 2010), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 143 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 |
|---|---|---|---|
| NDN | Cement, Bone, Vertebroplasty | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Dfine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091310 | ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 | GEI | 2010-08-11 | 464 |
| K090986 | STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) | NDN | 2009-12-30 | 267 |
| K072496 | MODIFICATION TO SPACE CPSXL BONE CEMENT | NDN | 2007-10-05 | 30 |
| K070351 | SPACE 360 DELIVERY SYSTEM | NDN | 2007-06-29 | 143 |
| K061531 | SPACE CPSXL BONE CEMENT | NDN | 2006-08-30 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Dfine, Inc..
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 Dfine, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Dfine, Inc.” (first 2006, latest 2010), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dfine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dfine, Inc. is 143 days.
Which FDA product codes appear under Dfine, Inc.?
The most frequent FDA product codes under this applicant name are NDN (Cement, Bone, Vertebroplasty, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 5 Dfine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NDN, Dfine, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.