FDA Registration
Active
🇺🇸 United States
EOS Small Bone System
Reg #: 3010156421
·
FEI: 3010156421
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- AMT Medical
- Registration Number
- 3010156421
- FEI Number
- 3010156421
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14298 169th Dr Se
- City
- Monroe
- State
- WA
- ZIP
- 98272
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112794
Owner / Operator
- Firm Name
- AMT Medical
- Operator Number
- 10043185
- Address
- 14298 169th Dr Se
- City
- Monroe
- State
- WA
- Postal Code
- 98272
- Country
- US
- Correspondent
- Macy Pyle
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2013-06-18 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-06-18 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-06-18 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2013-06-18 |
Proprietary Names
EOS Small Bone System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)