FDA 510(k)

德普康迪尤特 LLIF 角度插入器

K 號：K212823 · 2021-11-01

決定日期2021-11-01

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

DePuy CONDUIT LLIF Angled Inserters is the device name listed in this FDA 510(k) record. The listed applicant is Enztec Limited. It received FDA 510(k) clearance on 2021-11-01 under 510(k) number K212823. 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 DePuy CONDUIT LLIF Angled Inserters?

DePuy CONDUIT LLIF Angled Inserters is a medical device that received FDA 510(k) clearance on 2021-11-01. The listed applicant is Enztec Limited. The 510(k) number is K212823.

When did DePuy CONDUIT LLIF Angled Inserters receive FDA 510(k) clearance?

DePuy CONDUIT LLIF Angled Inserters received FDA 510(k) clearance on 2021-11-01, under 510(k) number K212823.

Who is the listed applicant for DePuy CONDUIT LLIF Angled Inserters?

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

What is the FDA product code for DePuy CONDUIT LLIF Angled Inserters?

The FDA product code for DePuy CONDUIT LLIF Angled Inserters is MAX.

其他以 Enztec Limited 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。

K232014CONDUIT™ ATP 插入器 K230876RI.KNEE 調節式胫骨切線導引器 K223671CONDUIT LLIF 直插式插入器 K220449DePuy CONDUIT LLIF SQUID 插入器

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。