# Trans1 Incorporated

- Location (FDA's records): Wilmington, NC
- FDA decisions: 14 (2004–2019): 14 510(k) clearances
- Names in FDA's records: Trans1 Incorporated (9); Trans1, Inc. (3); Trans1 (2)
- Product codes: KWQ (7), MAX (4), MRW (2), HRX (1)
- Predicates its devices cite: 17 (9 its own); citations of its devices by later devices: 31 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Sofamor Danek USA,Inc.: 2 (https://510kreport.com/company/sofamor-danek-usa)
- Spineology, Inc.: 1 (https://510kreport.com/company/spineology)
- Pioneer Surgical Technology: 1 (https://510kreport.com/company/pioneer-surgical-technology)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Life Spine, Inc.: 1 (https://510kreport.com/company/life-spine)

## Firms that cite its devices most
- Choicespine, LP: 5 (https://510kreport.com/company/choicespine)
- Amendia, Inc.: 2 (https://510kreport.com/company/amendia)
- Benvenue Medical, Inc.: 1 (https://510kreport.com/company/benvenue-medical)
- Nlt Spine, Ltd.: 1 (https://510kreport.com/company/nlt-spine)
- Ldr Spine USA: 1 (https://510kreport.com/company/ldr-spine-usa)
- Spinal USA: 1 (https://510kreport.com/company/spinal-usa)
- Transcorp: 1 (https://510kreport.com/company/transcorp)
- Spinal Devices, LLC: 1 (https://510kreport.com/company/spinal-devices)

## Its most-cited devices
- K073515: TRANS1 Facet Screw (2008), cited by 11
- K032891: TRANS1 Trans-Sacral Spinal Access and Preparation Kit (2004), cited by 3
- K100210: TRANS1 Lateral Intervertebral Fusion Device, T (2010), cited by 3
- K120991: TRANS1 Interbody Fusion System (2012), cited by 3
- K040426: TRANS1 Axial Fixation System (2004), cited by 2
- K123997: TRANS1LATERAL Interbody Fusion System (2013), cited by 2

## Recent decisions
- K192792: TranS1 AxiaLIF Plus System (Nov 20, 2019)
- K191791: TranS1 Interbody Fusion System (Sep 25, 2019)
- K123997: TRANS1LATERAL Interbody Fusion System (Apr 1, 2013)
- K120991: TRANS1 Interbody Fusion System (Aug 23, 2012)
- K102334: TRANS1 Axialif Plus (Mar 14, 2011)
- K100210: TRANS1 Lateral Intervertebral Fusion Device, T (Aug 26, 2010)
- K092124: Axialif 2L, Axialif 2-Level System, Axialif Apollo, Axialif II (Jan 21, 2010)
- K073643: TRANS1 Axialif 2-Level or II System (Apr 28, 2008)

Source page: https://510kreport.com/company/trans1