HomeAustraliaField Orthopaedics Pty, Ltd.

Field Orthopaedics Pty, Ltd.

Australia · Brisbane
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Australia, Israel — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
11listed device types
Class I 7Class II 4Class III 0
plus 11 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
17active ARTG entries
Class I 8IIa 6IIb 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States11 registration records, 4 510(k), 0 PMA, 8 excluded
Saudi Arabia0 confirmed, 3 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: FIELD ORTHOPAEDICS
Same-named companies — This database also contains companies with near-identical names: FIELD ORTHOPAEDICS. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Australia
City
Brisbane

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
FIELD ORTHOPAEDICS PTY LTD
ABN
20607190830
Registration status
Active
Legal form
Australian Private Company
Registered address
QLD, 4005

Business registration data from Australian Business Register, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12018 · K180348
12020 · K200043
12023 · K230118
12024 · K241695

FDA listed device types

showing 8 of 11
Bit, Drill 1Gauge, Depth 1Countersink 1Needle, Suturing, Disposable 1Stylet, Surgical, General & Plastic Surgery 1Orthopedic Manual Surgical Instrument 1Orthopedic Tray 1Pin, Fixation, Smooth 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241695Extremity All Suture System2024-09-12
USK230118Bony Trauma Extremity System (BTES) Screw Range, NX Nail2023-02-16
USK200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range2020-03-23

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