FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
CustomizedBone Service
K Number: K160707
·
Decision Dec 17, 2016
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
55
Applicant Total
5
Review Days
278
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Basic Information
- Device Name
- CustomizedBone Service
- K Number
- K160707
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5330
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fin-Ceramica Faenza S.P.A.
- Date Received
- March 14, 2016
- Decision Date
- December 17, 2016
- Product Code
- GXN
- 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 |
|---|---|---|---|
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | FDA class 2 | Neurology |
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