FDA Registration
Active
🇺🇸 United States
RIALTO SI Fusion System
Reg #: 1824199
·
FEI: 1824199
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- WARSAW ORTHOPEDIC, INC.
- Registration Number
- 1824199
- FEI Number
- 1824199
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2500 SILVEUS CROSSING
- City
- WARSAW
- State
- IN
- ZIP
- 46582
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161210
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2016-10-17 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2016-10-17 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2016-10-17 |
Proprietary Names
RIALTO SI Fusion System
Establishment Types
Manufacture Medical Device