FDA Registration
Active
🇺🇸 United States
DIAMOND ORTHOPEDIC
Reg #: 3013540005
·
FEI: 3013540005
·
Expires 2026
Products
18
Proprietary Names
22
Establishment Types
3
Classifications
18
Registration Details
- Registration Name
- DIAMOND ORTHOPEDIC
- Registration Number
- 3013540005
- FEI Number
- 3013540005
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1669 Federal Ave
- City
- Gastonia
- State
- NC
- ZIP
- 28052
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180932
Owner / Operator
- Firm Name
- Diamond Orthopedic
- Operator Number
- 10054574
- Address
- 1669 Federal Ave
- City
- Gastonia
- State
- NC
- Postal Code
- 28052
- Country
- US
- Correspondent
- Roy Bivens
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2019-03-22 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2017-04-04 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2017-04-04 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2017-04-04 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2023-12-27 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2023-12-27 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-12-27 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2017-04-04 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2024-07-29 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2017-04-04 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2017-04-04 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2017-04-04 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2017-04-04 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2017-04-04 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2019-03-22 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2017-04-04 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2019-03-22 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2017-04-04 |
Proprietary Names
Diamond Orthopedic Forceps
Diamond Orthopedic Bone Tap
Diamond Orthopedic Manual Surgical Instrument
Diamond Orthopedic Countersink
Fully Threaded Tapered Headless Compression
Diamond Orthopedic Screwdriver
Diamond Orthopedic Washer
Diamond Orthopedic Drill Bit
Diamond Orthopedic Pin
Diamond Orthopedic Surgical Tray
Diamond Orthopedics Wire Cutter
Diamond Orthopedic Drill Brace
Diamond Orthopedic Bone Screw Starter
Diamond Orthopedic Guide, Surgical, Instrument
Diamond Orthopedic Depth Guage
Diamond Orthopedic External Fixation Screws
Diamond Orthopedic Cortical Screws
Diamond Orthopedic Headless Compression Screws
Diamond Orthopedic Pins and Guide Wires
Diamond Orthopedic Cancellous Screws
Diamond Orthopedic Stylet, Surgical
Diamond Orthopedic Prosthesis Driver
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)