FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VSP Cranial System
K Number: K151285
·
Decision Sep 23, 2016
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
3
Applicant Total
12
Review Days
498
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Basic Information
- Device Name
- VSP Cranial System
- K Number
- K151285
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3D Systems, Inc.
- Date Received
- May 14, 2015
- Decision Date
- September 23, 2016
- Product Code
- PPT
- 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 |
|---|---|---|---|
| PPT | Cranial Surgical Planning And Instrument Guides | FDA class 2 | Neurology |
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