FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Vantage PSI System
K Number: K193432
·
Decision Nov 9, 2020
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
6
Applicant Total
5
Review Days
335
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Basic Information
- Device Name
- Vantage PSI System
- K Number
- K193432
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3110
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3D Systems
- Date Received
- December 10, 2019
- Decision Date
- November 9, 2020
- Product Code
- OYK
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| OYK | Ankle Arthroplasty Implantation System | FDA class 2 | Orthopedic |
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