TranS1 Interbody Fusion System
FDA 510(k) K191791 · Trans1
510(k) numberK191791
Submission
- Device name
- TranS1 Interbody Fusion System
- Applicant
- Trans1
Wilmington, NC, US - Received
- July 3, 2019
- Decision date
- September 25, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K192792 | TranS1 AxiaLIF Plus SystemKWQ · Traditional | 11/20/2019SE |
| 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 Interbody Fusion System cleared by the FDA?
TranS1 Interbody Fusion System (K191791) received a 510(k) decision of Substantially Equivalent on September 25, 2019, 84 days after the submission was received.
What is the product code of K191791?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.