FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)
K Number: K250123
·
Decision Sep 29, 2025
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
79
Applicant Total
14
Review Days
255
Basic Information
- Device Name
- Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)
- K Number
- K250123
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hager& Meisinger GmbH
- Date Received
- January 17, 2025
- Decision Date
- September 29, 2025
- Product Code
- DZL
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZL | Screw, Fixation, Intraosseous | FDA class 2 | Dental |
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