Alignment/Rotation Guide, Knee

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls on record, checked 25 Oct 2026.

Trade Name

Sigma

Generic Name

Orthopaedic prosthesis implantation positioning instrument, reusable

Device Name

Alignment/Rotation Guide, Knee

Model / Ref / Catalog

9505-01-274, 950501274

Primary DI / UDI-DI

10603295225775

Basic UDI-DI

0603295a003959A

Direct Marketing DI

10603295225775

FDA Product Code

HWT

EMDN Code

L091199 Orthopaedic prosthetics instruments, reusable - other

GMDN Term

Orthopaedic prosthesis implantation positioning instrument, reusable

Device Class

Class I

Regulation Number

888.4800

Market of Registration

Ireland

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

EUDAMED SRN

IE-MF-000007377

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