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Data / Medical devices / Australia / Field Orthopaedics

Field Orthopaedics: FDA-registered device maker in Teneriffe Queensland, Australia, 4 510(k) clearances

Field Orthopaedics is registered with the FDA (registration 3015131017) in Teneriffe Queensland, Australia. It lists 11 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 12, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Field Orthopaedics
FDA registration number
3015131017
Address
30 Florence Street, Teneriffe Queensland, Australia, 4005
Owner or operator
Field Orthopaedics Pty Ltd (10058631)
Roles
Specification developer
First device listed
December 12, 2018
Registered through
2026
Brand names listed
BTES-NX Extremity System, Bony Trauma Extremity System (BTES) Screw Range - NX Nail System, Cannulated Hex Driver (various), Cannulated Torx Driver (various), Countersink, Depth Gauge (various), Extremity All Suture System, FO Micro Cleaning Stylet and more

Devices it lists

DeviceProduct codeClassRoleSource
Bit, DrillHTW1Specification developeraccessdata.fda.gov
CountersinkHWW1Specification developeraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Specification developeraccessdata.fda.gov
Gauge, DepthHTJ1Specification developeraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Specification developeraccessdata.fda.gov
Orthopedic TrayOJH1Specification developeraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Specification developeraccessdata.fda.gov
Plate, Fixation, BoneHRS2Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Specification developeraccessdata.fda.gov
Stylet, Surgical, General & Plastic SurgeryGAH1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 12, 2024K241695Extremity All Suture SystemMBISubstantially EquivalentField Orthopaedicsaccessdata.fda.gov
February 16, 2023K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailHWCSubstantially EquivalentField Orthopaedics Pty, Ltd.accessdata.fda.gov
March 23, 2020K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw RangeHRSSubstantially EquivalentField Orthopaedics Pty, Ltd.accessdata.fda.gov
July 17, 2018K180348Field Orthopaedics Micro Screw SystemHWCSubstantially EquivalentField Orthopaedics Pty, Ltd.accessdata.fda.gov

Compare with other makers

Updated September 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.