FDA Registration
Active
🇺🇸 United States
MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System
Reg #: 3009941480
·
FEI: 3009941480
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- LISI MEDICAL REmmele
- Registration Number
- 3009941480
- FEI Number
- 3009941480
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 17701 198th Ave NW
- City
- Big Lake
- State
- MN
- ZIP
- 55309
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190895
Owner / Operator
- Firm Name
- LISI MEDICAL Remmele
- Operator Number
- 10042271
- Address
- 17701 198th Ave
- City
- Big Lake
- State
- MN
- Postal Code
- 55309
- Country
- US
- Correspondent
- Stephanie Potel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2022-11-10 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2022-11-10 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-11-10 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2022-11-10 |
Proprietary Names
MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)