FDA Registration
Active
🇺🇸 United States
ALTES
Reg #: 3005819474
·
FEI: 3005819474
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Choice Spine
- Registration Number
- 3005819474
- FEI Number
- 3005819474
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 400 Erin Drive
- City
- Knoxville
- State
- TN
- ZIP
- 37919
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061482
Owner / Operator
- Firm Name
- CHOICE SPINE, LLC
- Operator Number
- 9090881
- Address
- 400 ERIN DRIVE
- City
- Knoxville
- State
- TN
- Postal Code
- 37919
- Country
- US
- Correspondent
- Kim - Finch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2017-03-03 |
Proprietary Names
ALTES
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility