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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is SpineCraft. It received FDA 510(k) clearance on 2026-03-04 under 510(k) 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. The listed applicant is SpineCraft. The 510(k) number is K260015.

When did ANTERIS Thoracolumbar Plate System receive FDA 510(k) clearance?

ANTERIS Thoracolumbar Plate System received FDA 510(k) clearance on 2026-03-04, under 510(k) number K260015.

Who is the listed applicant for ANTERIS Thoracolumbar Plate System?

The FDA 510(k) record lists SpineCraft as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTERIS Thoracolumbar Plate System?

The FDA product code for ANTERIS Thoracolumbar Plate System is KWQ.

Other records listing SpineCraft as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.

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.

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