FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APEX 3D Total Ankle Replacement System
K Number: K240259
·
Decision Jun 24, 2024
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
65
Applicant Total
34
Review Days
145
Basic Information
- Device Name
- APEX 3D Total Ankle Replacement System
- K Number
- K240259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3110
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paragon 28, Inc.
- Date Received
- January 31, 2024
- Decision Date
- June 24, 2024
- 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 |
Similar 510(k) Clearances
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|---|---|---|---|
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