The Karma® Fixation System
K-Number: K242527 · 2025-05-21
ApplicantSpinal Elements, Inc.
Decision Date2025-05-21
Product CodeMRW
DecisionSubstantially Equivalent
Device Summary
The Karma® Fixation System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2025-05-21 under approval number K242527. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the The Karma® Fixation System?
The Karma® Fixation System is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K242527.
When was The Karma® Fixation System approved by the FDA?
The Karma® Fixation System received FDA 510(k) clearance on 2025-05-21, under approval number K242527.
What company makes The Karma® Fixation System?
The Karma® Fixation System is manufactured by Spinal Elements, Inc..
What is the FDA product code for The Karma® Fixation System?
The FDA product code for The Karma® Fixation System is MRW.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.