FDA Registration
Active
🇺🇸 United States
HURON TOOL & CUTTER GRINDING
Reg #: 3004358587
·
FEI: 3004358587
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- HURON TOOL & CUTTER GRINDING
- Registration Number
- 3004358587
- FEI Number
- 3004358587
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 485 Smith Street
- City
- Farmingdale
- State
- NY
- ZIP
- 11735
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133256
Owner / Operator
- Firm Name
- HURON TOOL & CUTTER GRINDING
- Operator Number
- 10043479
- Address
- 485 SMITH STREET
- City
- Farmingdale
- State
- NY
- Postal Code
- 11735
- Country
- US
- Correspondent
- DANIELLE AVENA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2016-01-13 |
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2016-01-13 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2016-01-13 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2016-01-13 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)