FDA Registration
Active
🇺🇸 United States
Contour II Spinal System
Reg #: 1038671
·
FEI: 1038671
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- EXACTECH, INC.
- Registration Number
- 1038671
- FEI Number
- 1038671
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2320 N.W. 66TH CT.
- City
- GAINESVILLE
- State
- FL
- ZIP
- 32653
- Country
- US
Regulatory Submissions
- 510(k) Number
- K053070
Owner / Operator
- Firm Name
- EXACTECH, INC.
- Operator Number
- 1038671
- Address
- 2320 N.W. 66TH CT., --
- City
- Gainesville
- State
- FL
- Postal Code
- 32653
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2009-02-23 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2009-02-23 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2009-02-23 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2009-02-23 |
Proprietary Names
Contour II Spinal System
Establishment Types
Manufacture Medical Device