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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

CASCADIA™ Interbody System

UDI-DI 10888857218482Basic UDI-DI 08858251005727TW

Class III · MDR · K2M, Inc.

Identification
Model
08858251005727TW
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

MDR 758873

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-06-18 · Expiry 2028-12-06

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

K2M, Inc.

SRN US-MF-000004440

US · Leesburg

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

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Canonical device page: /device/cascadiatm-interbody-system-8482 · UDI page: /udi/10888857218482

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