FDA 510(k)

雙XSLIM® T/PLIF

K 號：K222203 · 2022-10-18

決定日期2022-10-18

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

DualXSLIM(R) T/PLIF is the device name listed in this FDA 510(k) record. The listed applicant is Amplify Surgical, Inc.. It received FDA 510(k) clearance on 2022-10-18 under 510(k) number K222203. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DualXSLIM(R) T/PLIF?

DualXSLIM(R) T/PLIF is a medical device that received FDA 510(k) clearance on 2022-10-18. The listed applicant is Amplify Surgical, Inc.. The 510(k) number is K222203.

When did DualXSLIM(R) T/PLIF receive FDA 510(k) clearance?

DualXSLIM(R) T/PLIF received FDA 510(k) clearance on 2022-10-18, under 510(k) number K222203.

Who is the listed applicant for DualXSLIM(R) T/PLIF?

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

What is the FDA product code for DualXSLIM(R) T/PLIF?

The FDA product code for DualXSLIM(R) T/PLIF is MAX.

其他以 Amplify Surgical, Inc. 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。

K211740雙倍X K192434雙X 腰椎間盤融合設備

相關器械（代碼：MAX）

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。

K261049SCALA® TLSpineart SA K261430TruLift可擴展系統Life Spine, Inc.K253011Catalyft PL 可擴展椎間體系統Medtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L脊椎系統Medtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SystemSeaSpine Orthopedics Corporation K253151Fule間體融合籠架系統Beijing Fule Science & Technology Development Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。