FDA Registration
Active
🇨🇭 Switzerland
CONCORDE® Bullet Lumbar Interbody System
Reg #: 3008114965
·
FEI: 3008114965
·
Expires 2025
Products
4
Proprietary Names
9
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MEDOS INTERNATIONAL SARL
- Registration Number
- 3008114965
- FEI Number
- 3008114965
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Chemin-Blanc 38
- City
- Le Locle Neuchatel
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K173787
Owner / Operator
- Firm Name
- Medos International SARL
- Operator Number
- 10031083
- Address
- 4600 Riverside Drive
- City
- Palm Beach Gardens
- State
- FL
- Postal Code
- 33410
- Country
- US
- Correspondent
- Karen Parker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2019-08-12 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2019-08-12 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2019-08-12 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2019-08-12 |
Proprietary Names
CONCORDE® Bullet Lumbar Interbody System
X-MESH® Expandable Cage System
CONCORDE® Curve Lumbar Interbody System
Stackable Cage System
BENGAL Stackable Cage System
CONCORDE® Inline Lumbar Interbody System
BENGAL System
Surgical Titanium Mesh System
OCELOT® Stackable Cage System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility