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Home›Australia›SIGNATURE ORTHOPAEDICS PTY LIMITED

SIGNATURE ORTHOPAEDICS PTY LIMITED

Australia · Sydney New South
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
40listed device types
Class I 12Class II 27Class III 1
plus 103 registration records and 46 510(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
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States103 registration records, 46 510(k), 0 PMA, 2 excluded
Manufacturer names merged into this page: SIGNATURE ORTHOPAEDICS PTY LIMITED · Signature Orthopaedics Europe Ltd
Same-named companies — This database also contains companies with near-identical names: Signature Orthopaedics Europe Ltd. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Australia
City
Sydney New South

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
SIGNATURE ORTHOPAEDICS PTY LTD
ABN
41106702416
Registration status
Active
Legal form
Australian Private Company
Registered address
NSW, 2067

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

12012
12014
12015
32016
42017
42018
52019
52020
22021
52022
22023
42024
82025
12026

FDA listed device types

showing 8 of 40
Posterior Cervical Screw System 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Screw, Fixation, Bone 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1Prosthesis, Hip, Femoral, Resurfacing 1Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head2026-03-12
USK253239Active-V Total Knee System; World Total Knee System2025-12-23
USK251771Cambridge Partial Knee2025-12-16

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