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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 a medical device manufactured by Medical Bees GmbH. It received FDA 510(k) clearance on 2025-11-06 under approval 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. It is manufactured by Medical Bees GmbH. The 510(k) number is K250423.

When was mb-FIX Cranial Stabilization Systems approved by the FDA?

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

What company makes mb-FIX Cranial Stabilization Systems?

mb-FIX Cranial Stabilization Systems is manufactured by Medical Bees GmbH.

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 →

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