AERO MIS Facet Fusion System
FDA 510(k) K243865 · Aurora Spine
510(k) numberK243865
Submission
- Device name
- AERO MIS Facet Fusion System
- Applicant
- Aurora Spine
Carlsbad, CA, US - Received
- December 17, 2024
- Decision date
- March 24, 2025
- 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 |
|---|---|---|
| K221047 | SILO TFX MIS Sacroiliac Joint Fixation SystemOUR · Traditional | 10/03/2022SE |
| K221399 | ZIP MIS Interspinous Fusion SystemPEK · Traditional | 07/08/2022SE |
| K220610 | Solo-LOVD · Traditional | 05/27/2022SE |
| K210521 | DEXA-C Cervical Interbody SystemODP · Traditional | 08/02/2021SE |
| K210325 | APOLLO Anterior Cervical Plate (ACP) SystemKWQ · Traditional | 03/23/2021SE |
| K141317 | Zip Mis Interspinous Fusion SystemPEK · Traditional | 11/17/2014SE |
| K140715 | Zip Mis Interspinous Fusion SystemPEK · Special | 04/17/2014SE |
| K133967 | Interbody Cage SystemMAX · Traditional | 01/31/2014SE |
| K133091 | Zip Mis Interspinous Fusion SystemPEK · Traditional | 11/27/2013SE |
Questions and answers
When was AERO MIS Facet Fusion System cleared by the FDA?
AERO MIS Facet Fusion System (K243865) received a 510(k) decision of Substantially Equivalent on March 24, 2025, 97 days after the submission was received.
What is the product code of K243865?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.