FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
K Number: K182711
·
Decision May 21, 2019
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
4
Review Days
236
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Basic Information
- Device Name
- Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
- K Number
- K182711
- 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
- September 27, 2018
- Decision Date
- May 21, 2019
- 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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