mb-FIX Cranial Stabilization Systems

FDA 510(k) K250423 · Medical Bees GmbH

Substantially Equivalent

510(k) numberK250423

Submission

Device name
mb-FIX Cranial Stabilization Systems
Applicant
Medical Bees GmbH
Emmingen-Liptingen, DE
Received
February 14, 2025
Decision date
November 6, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HBL – Holder, Head, Neurosurgical (Skull Clamp)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4460
Specialty
Neurology

Other 510(k)s with product code HBL

510(k)DeviceApplicantDecision
K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO…HBL · Special Pro Med Instruments GmbH07/26/2024SE
K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)HBL · Traditional Pro Med Instruments GmbH04/24/2024SE
K203505DORO QR3 Headrest System (Aluminum)HBL · Traditional Pro Med Instruments GmbH03/29/2021SE
K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull…HBL · Traditional Pro Med Instruments GmbH06/02/2020SE
K191740DORO LUCENT® iXI and iMRI Headrest SystemHBL · Traditional Pro Med Instruments GmbH02/21/2020SE
K191701Arcus Head Fixation FrameHBL · Traditional Mri Interventions, Inc.11/15/2019SE
K191979DORO QR3 XTom Headholder SystemHBL · Traditional Pro Med Instruments GmbH10/22/2019SE
K163322TZ SKULL PIN AdultHBL · Traditional Tz Medical, Inc.02/23/2017SE
K142238MAYFIELD Skull ClampHBL · Traditional Integra LifeSciences Corporation11/24/2014SE
K141950HFD100 Rocker Arm AccessoryHBL · Special Imris, Inc.09/04/2014SE

Questions and answers

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

mb-FIX Cranial Stabilization Systems (K250423) received a 510(k) decision of Substantially Equivalent on November 6, 2025, 265 days after the submission was received.

What is the product code of K250423?

The FDA product code is HBL – Holder, Head, Neurosurgical (Skull Clamp), a Class II (moderate risk) device regulated under 21 CFR 882.4460.