FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Balanced Knee System Uni
K Number: K211471
·
Decision Dec 16, 2021
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
113
Applicant Total
14
Review Days
219
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Basic Information
- Device Name
- Balanced Knee System Uni
- K Number
- K211471
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3520
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Development Corporation
- Date Received
- May 11, 2021
- Decision Date
- December 16, 2021
- Product Code
- HSX
- 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 |
|---|---|---|---|
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
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