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Spinal Frontiers · Regulatory Watch · FDA decision

Alphatec clears additions to its Calibrate expandable interbody range

FDA decision · Alphatec Spine

21 October 2026

Alphatec's Calibrate MAX and Calibrate CCX interbody systems, with and without NanoTec surface, were cleared as lumbar fusion devices, also coded as vertebral body replacement devices.

Type
FDA decision
Company
Alphatec Spine
Device
Calibrate MAX and CCX interbody systems, including NanoTec versions
Date
21 October 2026
Jurisdiction
US
Classification
510(k) K262646 (MAX; MQP)
Source
FDA 510(k) database

Official source →Source checked

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