Trans1 Incorporated: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Trans1 Incorporated” (first 2005, latest 2012), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 124 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 | 1 | 143 |
| 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 5 | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| MRW | System, Facet Screw Spinal Device | 2 | 2 |
Review panels
- Orthopedic (9)
Most recent Trans1 Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120991 | TRANS1 INTERBODY FUSION SYSTEM | MAX | 2012-08-23 | 143 |
| K102334 | TRANS1 AXIALIF PLUS | KWQ | 2011-03-14 | 209 |
| K100210 | TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T | MAX | 2010-08-26 | 213 |
| K092124 | AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II | KWQ | 2010-01-21 | 190 |
| K073643 | TRANS1 AXIALIF 2-LEVEL OR II SYSTEM | KWQ | 2008-04-28 | 124 |
| K073515 | TRANS1 FACET SCREW | MRW | 2008-03-11 | 88 |
| K073514 | TRANS1 AXIAL FIXATON SYSTEM | KWQ | 2008-01-11 | 28 |
| K051856 | TRANS1 FACET SCREWS | MRW | 2005-09-26 | 80 |
| K050965 | TRANS1 AXIALIF SYSTEM | KWQ | 2005-06-14 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Trans1 Incorporated.
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.
- Trans1, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Trans1 Incorporated?
FDA lists 9 510(k) clearances under the applicant name “Trans1 Incorporated” (first 2005, latest 2012), 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 Trans1 Incorporated?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trans1 Incorporated is 124 days.
Which FDA product codes appear under Trans1 Incorporated?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 5); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); MRW (System, Facet Screw Spinal Device, 2).
Next steps
- See all 9 Trans1 Incorporated clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Trans1 Incorporated'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.