FDA Registration Number: 3004067876

Last Validated: September 15, 2021

Status: Valid

Valid2021 U.S. FDA Medical Device Establishment Registration

ORTHOSERVICE AG

Establishment Information

Via Milano 7
Chiasso Ticino, CH 6830

U.S. Agent and Official Correspondent

Registrar Corp
144 Research Drive
Hampton VA, USA 23666
Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by U.S. FDA.

Listings on file with FDA

Device Name Product Code Status Last Validated  
Cage, Knee ITM Valid September 14, 2021

Device Listing

Device Name

Cage, Knee

Product Code

ITM

Company Function(s)

Manufacturer

Proprietary Name(s)

FUNCTIONAL KNEE BRACE
Joint, Hip, External Brace ITS Valid September 14, 2021

Device Listing

Device Name

Joint, Hip, External Brace

Product Code

ITS

Company Function(s)

Manufacturer

Proprietary Name(s)

HIPCROSS
Splint, Hand, And Components ILH Valid September 14, 2021

Device Listing

Device Name

Splint, Hand, And Components

Product Code

ILH

Company Function(s)

Manufacturer

Proprietary Name(s)

SPLINT,HAND AND COMPONENTS
HAND
FINGER
WRIST
HUMB SPLINTS
;VARIOUS
Orthosis, Thoracic IPT Valid September 14, 2021

Device Listing

Device Name

Orthosis, Thoracic

Product Code

IPT

Company Function(s)

Manufacturer

Proprietary Name(s)

HYPEREXTENSION BRACE
DORSO-LUMBAR SUPPORT
Orthosis, Foot Drop OHI Valid September 14, 2021

Device Listing

Device Name

Orthosis, Foot Drop

Product Code

OHI

Company Function(s)

Manufacturer

Proprietary Name(s)

AFO Light
AFO Extrastrong
AFO Rigid

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