DeviceClearance

The Karma® Fixation System— 510(k) K242527

Substantially Equivalent

Spinal Elements, Inc.

FDA 510(k) clearance K242527 for The Karma® Fixation System, Substantially Equivalent on 2025-05-21. Applicant: Spinal Elements, Inc..

Clearance details

Applicant
Spinal Elements, Inc.
Product code
Code MRW
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.