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FDA 510(k)

mb-FIX Cranial Stabilization Systems

K-Number: K250423 · 2025-11-06

ApplicantMedical Bees GmbH
Decision Date2025-11-06
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

mb-FIX Cranial Stabilization Systems is the device name listed in this FDA 510(k) record. The listed applicant is Medical Bees GmbH. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K250423. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the mb-FIX Cranial Stabilization Systems?

mb-FIX Cranial Stabilization Systems is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Medical Bees GmbH. The 510(k) number is K250423.

When did mb-FIX Cranial Stabilization Systems receive FDA 510(k) clearance?

mb-FIX Cranial Stabilization Systems received FDA 510(k) clearance on 2025-11-06, under 510(k) number K250423.

Who is the listed applicant for mb-FIX Cranial Stabilization Systems?

The FDA 510(k) record lists Medical Bees GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for mb-FIX Cranial Stabilization Systems?

The FDA product code for mb-FIX Cranial Stabilization Systems is HBL.

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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.

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