FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
mb-FIX Cranial Stabilization Systems
K Number: K250423
·
Decision Nov 6, 2025
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
49
Applicant Total
1
Review Days
265
Basic Information
- Device Name
- mb-FIX Cranial Stabilization Systems
- K Number
- K250423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4460
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Bees GmbH
- Date Received
- February 14, 2025
- Decision Date
- November 6, 2025
- Product Code
- HBL
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | FDA class 2 | Neurology |
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