FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
USTOMED Bone Fixation/Bone Augmentation Systems - PIN
K Number: K243190
·
Decision Jun 27, 2025
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
79
Applicant Total
1
Review Days
270
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Basic Information
- Device Name
- USTOMED Bone Fixation/Bone Augmentation Systems - PIN
- K Number
- K243190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ustomed Instrumente Ulrich Storz GmbH & Co. KG
- Date Received
- September 30, 2024
- Decision Date
- June 27, 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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