FDA 510(k)

ANTERIS 胸腰椎板系統

K 號：K260015 · 2026-03-04

決定日期2026-03-04

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

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.

常見問題

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.

其他以 SpineCraft 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253260ORIO-3D 金屬網架系統

相關器械（代碼：KWQ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262149corra®脊椎板系統Carlsmed, Inc.K261309Palisades™ 壁壘板系統Bethesda Medical Devices, LLC K252776ARIES 前頸椎板系統ZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P 頸椎前方板系統L&K BIOMED Co., Ltd.K260570corra™脊椎板系統Carlsmed, Inc.K260697VyPlate™ 頸椎前方板系統Vy Spine, LLC

官方來源

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