FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Fusion Craniofacial Implant; Fusion Skull Implant
K Number: K250334
·
Decision Jul 25, 2025
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
4
Review Days
170
Basic Information
- Device Name
- Fusion Craniofacial Implant; Fusion Skull Implant
- K Number
- K250334
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kelyniam Global, Inc.
- Date Received
- February 5, 2025
- Decision Date
- July 25, 2025
- Product Code
- GWO
- 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 |
|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | FDA class 2 | Neurology |
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