FIELD ORTHOPAEDICS

FDA Device Registration & Listing · Teneriffe Queensland, AU · Registration 3015131017

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015131017
FEI Number
3015131017
Entity Name
FIELD ORTHOPAEDICS
City/State/Country
Teneriffe Queensland, AU
Establishment Address
30 Florence Street, Teneriffe Queensland 4005, AU
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Field Orthopaedics Pty Ltd (Owner Number: 10058631)
Owner / Operator Contact Address
30 Florence Street, Teneriffe, AU-QLD 4005, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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) K-wire (various) Micro Screw (various sizes) Pin and K-Wire Tray and Lid Micro Screw System Tray and Lid NX Nail System Tray and Lid

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2024-12-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-12-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-12-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-09-16
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-09-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-09-16
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2019-11-26
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2019-11-26
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-11-26
HWW Countersink Orthopedic Class 1 888.4540 2019-11-26
HTW Bit, Drill Orthopedic Class 1 888.4540 2019-11-26
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2018-12-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-12
OJH Orthopedic Tray General, Plastic Surgery Class 1 878.4800 2019-12-04

Official Correspondent

Jillianne McKenzie

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Field Orthopaedics Pty Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

Similar Registrations

Registration Number Establishment Name Location
3027516563 STAR SPORTS MEDICINE CO., LTD. Beijing, CN
3016678045 Schneider ASR B.V. Rotterdam-Albrandswaard Zuid-Holland, NL
9610612 AESCULAP AG TUTTLINGEN, DONAU Baden-Wurttemberg, DE
3008392711 ANQING KANGMINGNA PACKAGING CO.,LTD Anqing Anhui, CN
3010331645 Arthrex, Inc. Ave Maria, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015131017. Last updated year: 2026. Please use registration number 3015131017 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.