The Karma® Fixation System
FDA 510(k) K242527 · Spinal Elements, Inc.
510(k) numberK242527
Submission
- Device name
- The Karma® Fixation System
- Applicant
- Spinal Elements, Inc.
Carlsbad, CA, US - Received
- August 26, 2024
- Decision date
- May 21, 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
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| K250920 | Arthrex Spine Compression FT ScrewMRW · Traditional | Arthrex, Inc. | 05/22/2025SE |
| K243865 | AERO MIS Facet Fusion SystemMRW · Traditional | Aurora Spine | 03/24/2025SE |
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Questions and answers
When was The Karma® Fixation System cleared by the FDA?
The Karma® Fixation System (K242527) received a 510(k) decision of Substantially Equivalent on May 21, 2025, 268 days after the submission was received.
What is the product code of K242527?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.