Trans1 Incorporated: FDA filings under this applicant name
FDA lists 14 510(k) clearances under 3 spellings of the applicant name “Trans1 Incorporated” (first 2004, latest 2019), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 108 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 | 1 | 96 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 68 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Trans1 Incorporated took a median 68 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 7 | 7 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| MRW | System, Facet Screw Spinal Device | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
Review panels
- Orthopedic (14)
Most recent Trans1 Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192792 | TranS1 AxiaLIF Plus System | KWQ | 2019-11-20 | 51 |
| K191791 | TranS1 Interbody Fusion System | MAX | 2019-09-25 | 84 |
| K123997 | TRANS1LATERAL INTERBODY FUSION SYSTEM | MAX | 2013-04-01 | 96 |
| 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 |
4 earlier clearances. See the full list in Caduvo.
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.
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Trans1 Incorporated (9)
- Trans1, Inc. (3)
- Trans1 (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Trans1 Incorporated?
FDA lists 14 510(k) clearances under 3 spellings of the applicant name “Trans1 Incorporated” (first 2004, latest 2019), across 4 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 108 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, 7); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); MRW (System, Facet Screw Spinal Device, 2).
Next steps
- See all 14 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 (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.