FDA Registration
Active
🇦🇺 Australia
FIELD ORTHOPAEDICS
Reg #: 3015131017
·
FEI: 3015131017
·
Expires 2026
Products
11
Proprietary Names
25
Establishment Types
1
Classifications
11
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Registration Details
- Registration Name
- FIELD ORTHOPAEDICS
- Registration Number
- 3015131017
- FEI Number
- 3015131017
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 30 Florence Street
- City
- Teneriffe Queensland
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K200043
Owner / Operator
- Firm Name
- Field Orthopaedics Pty Ltd
- Operator Number
- 10058631
- Address
- 30 Florence Street
- City
- Teneriffe
- State
- Queensland
- Postal Code
- 4005
- Country
- AU
- Correspondent
- Jillianne McKenzie
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2024-12-05 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-12-05 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2022-12-05 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2024-09-16 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2024-09-16 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2019-11-26 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-11-26 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2019-11-26 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2019-11-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2019-11-26 |
| Orthopedic Tray | OJH | Class 1 | General, Plastic Surgery | No | 2019-12-04 |
Proprietary Names
Needle (various)
NX Nail
BTES-NX Extremity System
Extremity All Suture System
K-wire (various)
Suture anchors (various)
Depth Gauge (various)
Guide Sleeve (various)
Pin Collet Insert
Micro Hex Driver (Cannulated) - various
Soft Tissue Protector
Surgical Handle (various)
Cannulated Torx Driver (various)
Inserter Handle (various)
Cannulated Hex Driver (various)
FO Micro Cleaning Stylet
Metaphyseal Cannulated Hand Drill (various)
Countersink
Micro Drill (Cannulated)
Thermally Hardened Cannulated Drill Bit (various)
Micro Screw (various sizes)
Pin and K-Wire Tray and Lid
Micro Screw System Tray and Lid
NX Nail System Tray and Lid
Bony Trauma Extremity System (BTES) Screw Range - NX Nail System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility