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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2025-05-21 under 510(k) 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. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K242527.

When did The Karma® Fixation System receive FDA 510(k) clearance?

The Karma® Fixation System received FDA 510(k) clearance on 2025-05-21, under 510(k) number K242527.

Who is the listed applicant for The Karma® Fixation System?

The FDA 510(k) record lists Spinal Elements, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Karma® Fixation System?

The FDA product code for The Karma® Fixation System is MRW.

Other records listing Spinal Elements, Inc. as applicant

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Related Devices (Code: MRW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261209Ion-LSurGenTec, LLCK253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.K253432DiversiVy™ Facet Screw SystemVy Spine, LLCK251714Ion-CSurGenTec, LLCK250679FFX Facet Fixation SystemSc MedicaK253190CORUS-LX ImplantProvidence Medical Technology, Inc.

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.

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