CarboFix clears navigated instruments for its carbon-fibre cervical implants

FDA decision · CarboFix Orthopedics

9 October 2026

Navigated instruments for use with CarboFix's radiolucent carbon-fibre/PEEK cervical implants were cleared as stereotaxic accessories.

Type: FDA decision
Company: CarboFix Orthopedics
Device: CarboClear Cervical Navigated Instruments
Date: 9 October 2026
Jurisdiction: US
Classification: 510(k) K263154 (OLO)
Source: FDA 510(k) database

Official source →Source checked

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