TRANS1 Facet Screw
FDA 510(k) K073515 · Trans1 Incorporated
510(k) numberK073515
Submission
- Device name
- TRANS1 Facet Screw
- Applicant
- Trans1 Incorporated
Wilmington, NC, US - Received
- December 14, 2007
- Decision date
- March 11, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRW – System, Facet Screw Spinal Device
- Device class
- Unclassified
- Implant
- Yes
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| 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 |
| K073514 | TRANS1 Axial Fixaton SystemKWQ · Special | 01/11/2008SE |
| K051856 | TRANS1 Facet ScrewsMRW · Traditional | 09/26/2005SE |
Questions and answers
When was TRANS1 Facet Screw cleared by the FDA?
TRANS1 Facet Screw (K073515) received a 510(k) decision of Substantially Equivalent on March 11, 2008, 88 days after the submission was received.
What is the product code of K073515?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.