FacetBRIDGE® System
FDA 510(k) K161798 · Ldr Spine USA, Inc.
510(k) numberK161798
Submission
- Device name
- FacetBRIDGE® System
- Applicant
- Ldr Spine USA, Inc.
Austin, TX, US - Received
- June 30, 2016
- Decision date
- August 4, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K162133 | VerteFIT Corpectomy Cage SystemMQP · Traditional | 05/16/2017SE |
| K161173 | Avenue® T TLIF CageOVD · Traditional | 09/28/2016SE |
| K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…MAX · Traditional | 03/31/2016SE |
| K152137 | FacetBRIDGE SystemMRW · Traditional | 01/25/2016SE |
| K151934 | ROI-C Titanium-Coated Implant SystemOVE · Traditional | 12/07/2015SE |
| K150765 | LDR Spine ROI-C Cervical Cage SystemOVE · Traditional | 09/17/2015SE |
| K142645 | Avenue T TLIF CageOVD · Traditional | 06/11/2015SE |
| K133363 | Interbridge Interspinous Posterior Fixation SystemPEK · Traditional | 03/07/2014SE |
| K123134 | Easyspine SystemNKB · Traditional | 02/01/2013SE |
| K121103 | LDR Spine USA Spine Tune, TL Spinal System, LDR Spine USA Easyspine, Posterior Spinal…NKB · Traditional | 08/24/2012SE |
Questions and answers
When was FacetBRIDGE® System cleared by the FDA?
FacetBRIDGE® System (K161798) received a 510(k) decision of Substantially Equivalent on August 4, 2016, 35 days after the submission was received.
What is the product code of K161798?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.