K242527
- 510(k) number
- K242527
- Device name
- The Karma® Fixation System
- Applicant
- Spinal Elements, Inc. CA · US
- Product code
- MRW — System, Facet Screw Spinal Device
- Decision date
- 2025-05-21
- Date received
- 2024-08-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K242527.pdf
Official FDA record: K242527
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.