FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
NextAR TKA Platform
K Number: K193559
·
Decision Jul 10, 2020
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
41
Applicant Total
4
Review Days
200
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Basic Information
- Device Name
- NextAR TKA Platform
- K Number
- K193559
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta Inernational SA
- Date Received
- December 23, 2019
- Decision Date
- July 10, 2020
- Product Code
- SBF
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| SBF | Orthopedic Augmented Reality | FDA class 2 | Neurology |
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