FDA Registration
Active
🇺🇸 United States
CONCORDE® Bullet Lumbar Interbody System
Reg #: 3009941480
·
FEI: 3009941480
·
Expires 2025
Products
4
Proprietary Names
3
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
- K173787
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 |
|---|---|---|---|---|---|
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2022-11-10 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2022-11-10 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2022-11-10 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-11-10 |
Proprietary Names
CONCORDE® Bullet Lumbar Interbody System
X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System
BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System,
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)