Name: Predicase
Price: 199 USD

K-number	K250423
Device name	mb-FIX Cranial Stabilization Systems
Applicant	Medical Bees GmbH
Product code	HBL
Device class	Class II
Decision date	Nov 6, 2025
Decision	Substantially Equivalent
Regulation	882.4460

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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mb-FIX Cranial Stabilization Systems

Everything you need for a 510(k) submission. Nothing you don't.