The Karma® Fixation System— 510(k) K242527
Substantially EquivalentSpinal Elements, Inc.
FDA 510(k) clearance K242527 for The Karma® Fixation System, Substantially Equivalent on 2025-05-21. Applicant: Spinal Elements, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Spinal Elements, Inc.
- Product code
- Code MRW
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
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