Eu Mdr Eu Md Class 1 On The Market 🇺🇸 United States

Surestep

Surestep, LLC · 🇺🇸 United States
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
00810080701151
Basic UDI-DI Code
0810080701970-ART-CFNJ
Reference
1970-ART-CF
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
Surestep, LLC

Additional Description

Our Surestep Hinged AFO is built with a specific purpose in mind. For children who present with excessive plantarflexion, the Surestep Hinged may be an appropriate solution. This orthosis provides more sagittal plane stability by utilizing a plantarflexion stop while allowing free dorsiflexion. This AFO incorporates flexible dorsum wings to provide triplanar stability and circumferential compression. The Surestep Hinged AFO is made with the Surestep Free Motion Hinges, which are lighter and lower profile than traditional ankle joints. These qualities reduce the bulk of the orthosis and aid in finding an appropriate shoe.

CND Nomenclature Codes

Code Description
Y06120601 PASSIVE ANKLE-FOOT ORTHOSES

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