FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Axiom PSR System
K Number: K223326
·
Decision Mar 30, 2023
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
6
Applicant Total
12
Review Days
150
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Basic Information
- Device Name
- Axiom PSR System
- K Number
- K223326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3110
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Restor3D
- Date Received
- October 31, 2022
- Decision Date
- March 30, 2023
- 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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