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Spinal Frontiers · Regulatory Watch · FDA decision

FDA clears an updated 7D Surgical navigation system

FDA decision · 7D Surgical

19 October 2026

A further 510(k) for the 7D Surgical image-guided navigation system was cleared as an orthopaedic stereotaxic instrument. The FDA record does not set out what changed or the cleared indications.

Type
FDA decision
Company
7D Surgical
Device
7D Surgical System (10-0001)
Date
19 October 2026
Jurisdiction
US
Classification
510(k) K260403 (OLO)
Source
FDA 510(k) database

Official source →Source checked

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