Cleared Traditional

K250423 - mb-FIX Cranial Stabilization Systems (FDA 510(k) Clearance)

K250423 · Medical Bees GmbH · Neurology device
Nov 2025
Decision
265d
Days
Class 2
Risk

K250423 is an FDA 510(k) clearance for the mb-FIX Cranial Stabilization Systems. This device is classified as a Holder, Head, Neurosurgical (skull Clamp) (Class II - Special Controls, product code HBL).

Submitted by Medical Bees GmbH (Emmingen-Liptingen, DE). The FDA issued a Cleared decision on November 6, 2025, 265 days after receiving the submission on February 14, 2025.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4460.

Submission Details

510(k) Number K250423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2025
Decision Date November 06, 2025
Days to Decision 265 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBL - Holder, Head, Neurosurgical (skull Clamp)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.4460