FDA Registration
Active
🇺🇸 United States
NextAR TKA Platform
Reg #: 3006639916
·
FEI: 3006639916
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Medacta USA, Inc.
- Registration Number
- 3006639916
- FEI Number
- 3006639916
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6386 Global Drive, Suite 101
- City
- Memphis
- State
- TN
- ZIP
- 38141
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193559
Owner / Operator
- Firm Name
- Medacta International SA
- Operator Number
- 10024526
- Address
- Strada Regina
- City
- Castel San Pietro
- State
- Ticino
- Postal Code
- 6874
- Country
- CH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2020-07-10 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2020-07-10 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2020-07-10 |
Proprietary Names
NextAR TKA Platform
Establishment Types
Complaint File Establishment per 21 CFR 820.198