Venus Facet Screw System
FDA 510(k) K120340 · Apollo Spine, Inc.
510(k) numberK120340
Submission
- Device name
- Venus Facet Screw System
- Applicant
- Apollo Spine, Inc.
Stoughton, MA, US - Received
- February 3, 2012
- Decision date
- October 19, 2012
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K120143 | Eclipse Vertebral Spacer System-CervicalODP · Special | 02/16/2012SE |
| K102636 | Zenith Pedicle SystemMNH · Traditional | 03/03/2011SE |
| K102121 | Eclipse Vertebral Spacer System-LumbarOVD · Traditional | 01/12/2011SE |
| K101588 | Eclipse Vertebral Spacer System-CervicalOVE · Traditional | 01/07/2011SE |
| K090751 | Comet Anterior Cervical Plate SystemKWQ · Special | 10/23/2009SE |
| K082504 | Apollo Anterior Cervical Plate SystemKWQ · Traditional | 01/27/2009SE |
Questions and answers
When was Venus Facet Screw System cleared by the FDA?
Venus Facet Screw System (K120340) received a 510(k) decision of Substantially Equivalent on October 19, 2012, 259 days after the submission was received.
What is the product code of K120340?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.