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Ortho-Care, Inc.

USA · Mchenry

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 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

8listed device types

Class I 7Class II 1Class III 0

plus 9 registration records and 1 510(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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

Class I 4IIa 4

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 States9 registration records, 1 510(k), 0 PMA, 111 excluded

Brazil0 confirmed, 36 excluded

Saudi Arabia0 confirmed, 12 excluded

Canada0 confirmed, 13 excluded

Manufacturer names merged into this page: ORTHO CAPE

Same-named companies — This database also contains companies with near-identical names: ORTHO CAPE. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11980 · K800752

FDA listed device types

Screwdriver 1Guide, Drill, Ligament 1Gauge, Depth 1Positioner, Socket 1Countersink 1Burr, Orthopedic 1Tap, Bone 1Screw, Fixation, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K800752	PRE-PADDED PLASTER/PARIS BAND/SPLINTS	1980-04-21

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Ortho-Care, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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