FDA Registration
Active
🇺🇸 United States
AMEND SURGICAL, INC.
Reg #: 3012161787
·
FEI: 3012161787
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AMEND SURGICAL, INC.
- Registration Number
- 3012161787
- FEI Number
- 3012161787
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14000 NW 126th Ter
- City
- Alachua
- State
- FL
- ZIP
- 32615
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161996
Owner / Operator
- Firm Name
- Amend Surgical, Inc.
- Operator Number
- 10051002
- Address
- 14000 NW 126th Ter
- City
- Alachua
- State
- FL
- Postal Code
- 32615
- Country
- US
- Correspondent
- Robby Lane
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2019-06-20 |
Establishment Types
Manufacture Medical Device