TRANS1 Axialif Plus
FDA 510(k) K102334 · Trans1 Incorporated
510(k) numberK102334
Submission
- Device name
- TRANS1 Axialif Plus
- Applicant
- Trans1 Incorporated
Wilmington, NC, US - Received
- August 17, 2010
- Decision date
- March 14, 2011
- 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
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More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K192792 | TranS1 AxiaLIF Plus SystemKWQ · Traditional | 11/20/2019SE |
| 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 |
| 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 cleared by the FDA?
TRANS1 Axialif Plus (K102334) received a 510(k) decision of Substantially Equivalent on March 14, 2011, 209 days after the submission was received.
What is the product code of K102334?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.