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Spinal Frontiers · Regulatory Watch · FDA decision

SeaSpine clears Virata pedicle screw system with navigated instruments

FDA decision · SeaSpine (Orthofix)

29 October 2026

Virata, a thoracolumbosacral pedicle screw system with modular and preassembled screws in titanium and cobalt chrome, was cleared for the usual degenerative, trauma, tumour and deformity indications, including paediatric scoliosis. It comes with instruments navigated on the Medtronic StealthStation.

Type
FDA decision
Company
SeaSpine (Orthofix)
Device
Virata Spinal Fixation System
Date
29 October 2026
Jurisdiction
US
Classification
510(k) K262731 (NKB; also KWP, OLO)
Source
FDA 510(k) database

Official source →Source checked

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