FDA Registration
Active
🇺🇸 United States
ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
Reg #: 3011577940
·
FEI: 3011577940
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Titan Spine, a Division of Medtronic
- Registration Number
- 3011577940
- FEI Number
- 3011577940
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8347 N Steven Rd
- City
- Milwaukee
- State
- WI
- ZIP
- 53223
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141953
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 |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2015-05-07 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2015-05-07 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2015-05-07 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2015-05-07 |
Proprietary Names
ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
Establishment Types
Manufacture Medical Device