ANTERIS Thoracolumbar Plate System
K-Number: K260015 · 2026-03-04
ApplicantSpineCraft
Decision Date2026-03-04
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ANTERIS Thoracolumbar Plate System is a medical device manufactured by SpineCraft. It received FDA 510(k) clearance on 2026-03-04 under approval number K260015. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ANTERIS Thoracolumbar Plate System?
ANTERIS Thoracolumbar Plate System is a medical device that received FDA 510(k) clearance on 2026-03-04. It is manufactured by SpineCraft. The 510(k) number is K260015.
When was ANTERIS Thoracolumbar Plate System approved by the FDA?
ANTERIS Thoracolumbar Plate System received FDA 510(k) clearance on 2026-03-04, under approval number K260015.
What company makes ANTERIS Thoracolumbar Plate System?
ANTERIS Thoracolumbar Plate System is manufactured by SpineCraft.
What is the FDA product code for ANTERIS Thoracolumbar Plate System?
The FDA product code for ANTERIS Thoracolumbar Plate System is KWQ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.