FDA Registration
Active
🇺🇸 United States
12.2mm One Step Reamer, Trauma Fixation Systems
Reg #: 3004358587
·
FEI: 3004358587
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
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
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 |
|---|---|---|---|---|---|
| Reamer | HTO | Class 1 | Orthopedic | No | 2020-12-07 |
Proprietary Names
12.2mm One Step Reamer, Trauma Fixation Systems
DynaFORCE MTP Cup Reamer, 20mm
DynaFORCE MTP Cup Reamer, 18mm
DynaFORCE MTP Cup Reamer, 22mm
DynaFORCE MTP Cup Reamer, 24mm
DynaFORCE MTP Cone Reamer, 24mm
DynaFORCE MTP Cone Reamer, 18mm
DynaFORCE MTP Cup Reamer, 16mm
DynaFORCE MTP Cone Reamer, 16mm
DynaFORCE MTP Cone Reamer, 22mm
DynaFORCE MTP Cone Reamer, 20mm
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)