FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Apex 3D Total Ankle Replacement System
K Number: K210390
·
Decision Mar 6, 2021
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
67
Applicant Total
50
Review Days
25
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Basic Information
- Device Name
- Apex 3D Total Ankle Replacement System
- K Number
- K210390
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3110
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paragon 28, Inc.
- Date Received
- February 9, 2021
- Decision Date
- March 6, 2021
- Product Code
- HSN
- 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 |
|---|---|---|---|
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
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