TranS1 AxiaLIF Plus System
FDA 510(k) K192792 · Trans1
510(k) numberK192792
Submission
- Device name
- TranS1 AxiaLIF Plus System
- Applicant
- Trans1
Wilmington, NC, US - Received
- September 30, 2019
- Decision date
- November 20, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | Vy Spine, LLC | 03/27/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | SpineCraft | 03/04/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K191791 | TranS1 Interbody Fusion SystemMAX · Traditional | 09/25/2019SE |
| K123997 | TRANS1LATERAL Interbody Fusion SystemMAX · Traditional | 04/01/2013SE |
| K120991 | TRANS1 Interbody Fusion SystemMAX · Traditional | 08/23/2012SE |
| K102334 | TRANS1 Axialif PlusKWQ · Traditional | 03/14/2011SE |
| K100210 | TRANS1 Lateral Intervertebral Fusion Device, TMAX · Traditional | 08/26/2010SE |
| K092124 | Axialif 2L, Axialif 2-LEVEL System, Axialif Apollo, Axialif IIKWQ · Traditional | 01/21/2010SE |
| K073643 | TRANS1 Axialif 2-LEVEL or II SystemKWQ · Traditional | 04/28/2008SE |
| K073515 | TRANS1 Facet ScrewMRW · Traditional | 03/11/2008SE |
| K073514 | TRANS1 Axial Fixaton SystemKWQ · Special | 01/11/2008SE |
| K051856 | TRANS1 Facet ScrewsMRW · Traditional | 09/26/2005SE |
Questions and answers
When was TranS1 AxiaLIF Plus System cleared by the FDA?
TranS1 AxiaLIF Plus System (K192792) received a 510(k) decision of Substantially Equivalent on November 20, 2019, 51 days after the submission was received.
What is the product code of K192792?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.