Trans1 Incorporated
United StatesFDA applicant, unverified
- Devices
- 9
What Trans1 Incorporated makes
Trans1 Incorporated manufactures spinal fixation and fusion devices, including facet screws, lateral intervertebral fusion implants, and axial interbody systems for surgical stabilization of the spine. Their portfolio includes modular interbody fusion systems, axial fixation solutions, and multi-level spinal constructs designed for anterior and lateral approaches. Products are intended for use in procedures such as degenerative disc disease treatment, spinal deformity correction, and trauma stabilization.
The company’s devices are classified under FDA Class II and Class U, with regulatory clearance via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, reflecting their authorised status under US medical device regulations. Trans1 Incorporated operates from the United States.
Catalogue
TRANS1 Facet Screw Ref K073515
Regimes: 510(k) Registry: 510(k)TRANS1 Facet Screws Ref K051856
Regimes: 510(k) Registry: 510(k)TRANS1 Lateral Intervertebral Fusion Device, T Ref K100210
Regimes: 510(k) Registry: 510(k)TRANS1 Axialif System Ref K050965
Regimes: 510(k) Registry: 510(k)TRANS1 Interbody Fusion System Ref K120991
Regimes: 510(k) Registry: 510(k)TRANS1 Axialif Plus Ref K102334
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
TRANS1 Axialif 2-Level Or Ii System Ref K073643
Regimes: 510(k) Registry: 510(k)TRANS1 Axial Fixaton System Ref K073514
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Trans1 Incorporated have in the registry?
The registry currently lists 9 devices for Trans1 Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Trans1 Incorporated's devices?
Among its 9 most recently registered devices, Trans1 Incorporated has devices listed in FDA 510(k) (9 devices).
What risk classes do Trans1 Incorporated's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Trans1 Incorporated's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Trans1 Incorporated in the registry?
The most recently registered devices listed for Trans1 Incorporated include TRANS1 FACET SCREW, TRANS1 FACET SCREWS, TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T and TRANS1 AXIALIF SYSTEM.