FDA Registration
Active
🇺🇸 United States
HURON TOOL & CUTTER GRINDING
Reg #: 3004358587
·
FEI: 3004358587
·
Expires 2026
Products
17
Proprietary Names
3
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- HURON TOOL & CUTTER GRINDING
- Registration Number
- 3004358587
- FEI Number
- 3004358587
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-02-20 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2013-02-20 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2025-12-29 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2021-02-11 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2013-12-30 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-03-18 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2013-12-30 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2025-12-29 |
| 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 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-12-30 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2013-12-30 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2013-12-30 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2025-12-29 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2020-12-07 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-02-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-02-20 |
Proprietary Names
DRILL BIT CANN AO 2X65MM ST
DRILL BIT CANN AO 2X65MM NS
DRILL HEAD RELIEF AO 2.5 NS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)