FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Quantum® Total Ankle Prosthesis
K Number: K191380
·
Decision Jan 29, 2020
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
67
Applicant Total
18
Review Days
251
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Basic Information
- Device Name
- Quantum® Total Ankle Prosthesis
- K Number
- K191380
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3110
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- In2bones Sas
- Date Received
- May 23, 2019
- Decision Date
- January 29, 2020
- 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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