Kompreda
FDA 510(k) K120597 · Custom Spine, Inc.
510(k) numberK120597
Submission
- Device name
- Kompreda
- Applicant
- Custom Spine, Inc.
Parsippany, NJ, US - Received
- February 28, 2012
- Decision date
- May 3, 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
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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 |
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| K111726 | Pathway AvidMAX · Traditional | 02/06/2012SE |
| K111774 | Pathway Model 07XXXXMAX · Special | 07/20/2011SE |
| K111099 | Issys LP Spinal Fixation SystemNKB · Special | 05/05/2011SE |
| K101151 | Regent Anterior Cervical PlateKWQ · Special | 05/19/2010SE |
| K092904 | Pathway Ivb/VbrODP · Traditional | 12/22/2009SE |
| K091134 | Custom Spine Regent Anterior Cervical PlateKWQ · Traditional | 08/17/2009SE |
| K090566 | Pathway AvidMAX · Traditional | 06/01/2009SE |
| K080281 | PathwayMAX · Traditional | 05/01/2008SE |
Questions and answers
When was Kompreda cleared by the FDA?
Kompreda (K120597) received a 510(k) decision of Substantially Equivalent on May 3, 2013, 430 days after the submission was received.
What is the product code of K120597?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.