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Home›USA›AVITUS ORTHOPAEDICS, INC. (SHELTON)

AVITUS ORTHOPAEDICS, INC. (SHELTON)

USA
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
4listed device types
Class I 2Class II 2Class III 0
plus 7 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 1Class II 2
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 States7 registration records, 5 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: Avitus Orthopaedics, Inc · AVITUS ORTHOPAEDICS, INC. (SHELTON)
Same-named companies — This database also contains companies with near-identical names: Avitus Orthopaedics, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA

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.

FDA 510(k) clearances by year

12015 · K152474
12017 · K170539
12021 · K210631
22023 · K231456

FDA listed device types

Instrument, Biopsy 1Syringe, Piston 1Orthopedic Manual Surgical Instrument 1Tray, Surgical, Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK231456Avitus® DragonWing Large Volume Autograft Delivery System2023-07-17
USK230492Avitus® Precision Autograft Delivery System2023-06-26
USK210631Avitus(r) Bone Harvester2021-03-31
BR80625390005Instrumental Estéril para Avitus® BoneClass II
BR80625390003Instrumental para Avitus BoneClass I
BR80625390004Avitus Bone HarvesterClass II

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