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Spinal Frontiers · Regulatory Watch · CE mark

Navient spine and cranial navigation transitions to EU MDR

CE mark · ClaroNav Kolahi (CKI)

7 October 2026

Toronto-based CKI announced MDR certification for its Navient navigation system, previously sold under the old Directive, which offers 2D fluoroscopy-based and CT/MRI-to-fluoro registration for spine.

Type
CE mark
Company
ClaroNav Kolahi (CKI)
Device
Navient image-guided navigation system and instruments
Date
7 October 2026
Jurisdiction
EU
Classification
EU MDR certificate (notified body not stated)
Source
SPINEMarketGroup (company announcement)

Official source →Source checked

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