Facet Fixx
FDA 510(k) K131417 · Nexxt Spine, LLC
510(k) numberK131417
Submission
- Device name
- Facet Fixx
- Applicant
- Nexxt Spine, LLC
Chesterland, OH, US - Received
- May 16, 2013
- Decision date
- July 12, 2013
- 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
Other 510(k)s with product code MRW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261209 | Ion-LMRW · Traditional | SurGenTec, LLC | 06/11/2026SE |
| K253676 | CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)MRW · Traditional | Providence Medical Technology, Inc. | 05/14/2026SE |
| K253432 | DiversiVy Facet Screw SystemMRW · Traditional | Vy Spine, LLC | 03/19/2026SE |
| K251714 | Ion-CMRW · Traditional | SurGenTec, LLC | 01/16/2026SE |
| K250679 | FFX Facet Fixation SystemMRW · Traditional | Sc Medica | 12/04/2025SE |
| K253190 | CORUS-LX ImplantMRW · Traditional | Providence Medical Technology, Inc. | 11/20/2025SE |
| K252153 | FFX Facet Fixation SystemMRW · Traditional | Sc Medica | 10/16/2025SE |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantMRW · Special | Providence Medical Technology, Inc. | 07/10/2025SE |
| K250920 | Arthrex Spine Compression FT ScrewMRW · Traditional | Arthrex, Inc. | 05/22/2025SE |
| K242527 | The Karma® Fixation SystemMRW · Traditional | Spinal Elements, Inc. | 05/21/2025SE |
More from Spinal Elements, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243838 | NEXXT MATRIXX® SI SystemOUR · Traditional | 03/14/2025SE |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate SystemKWQ · Special | 03/22/2024SE |
| K231799 | INERTIA® CONNEXX Modular Pedicle Screw SystemNKB · Special | 07/20/2023SE |
| K221905 | INERTIA CONNEXX Modular Pedicle Screw SystemNKB · Special | 07/28/2022SE |
| K220291 | NEXXT SPINE NAVIGATION SystemOLO · Traditional | 03/31/2022SE |
| K202230 | NEXXT MATRIXX Stand Alone ALIF SystemOVD · Traditional | 12/15/2020SE |
| K202192 | STRUXXURE®-L and STRUXXURE®-A Plate SystemKWQ · Traditional | 09/17/2020SE |
| K200969 | NEXXT MATRIXX SystemMAX · Special | 05/21/2020SE |
| K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemOVE · Special | 03/23/2020SE |
| K193412 | NEXXT MATRIXX SystemPLR · Traditional | 02/24/2020SE |
Questions and answers
When was Facet Fixx cleared by the FDA?
Facet Fixx (K131417) received a 510(k) decision of Substantially Equivalent on July 12, 2013, 57 days after the submission was received.
What is the product code of K131417?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.