The Karma® Fixation System — Spinal Elements, Inc. (510(k) K242527)
The Karma® Fixation System — Spinal Elements, Inc. (510(k) K242527) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: The Karma® Fixation System; Applicant: Spinal Elements, Inc.; Clearance track: 510(k).
| Device name | The Karma® Fixation System |
|---|---|
| Applicant | Spinal Elements, Inc. |
| Clearance track | 510(k) |
| Submission number | K242527 |
| Decision | Substantially Equivalent |
| Decision date | 2025-05-21 |
| Date received | 2024-08-26 |
| Product code | MRW |
| Device class | U |
| Medical specialty | Unknown |
| Applicant location | CA, US |
| Source | openFDA device |
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$1999/mo
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