FDA Registration
Active
🇺🇸 United States
KTW - APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Reg #: 3011302692
·
FEI: 3011302692
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EPTAM WEST LLC
- Registration Number
- 3011302692
- FEI Number
- 3011302692
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 615 Wooten Rd Ste 150
- City
- Colorado Springs
- State
- CO
- ZIP
- 80915
- Country
- US
Regulatory Submissions
- 510(k) Number
- K992837
Owner / Operator
- Firm Name
- EPTAM WEST LLC
- Operator Number
- 10048254
- Address
- 615 Wooten Rd., Suite 150
- City
- Colorado Springs
- State
- CO
- Postal Code
- 80915
- Country
- US
- Correspondent
- Tristan Manus
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2017-04-14 |
Proprietary Names
KTW - APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)