FDA 510(k)

Curiteva多孔PEEK腰椎間融合系統

K 號：K233744 · 2024-01-18

決定日期2024-01-18

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Curiteva Porous PEEK Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Curiteva, Inc.. It received FDA 510(k) clearance on 2024-01-18 under 510(k) number K233744. 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 Curiteva Porous PEEK Lumbar Interbody Fusion System?

Curiteva Porous PEEK Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Curiteva, Inc.. The 510(k) number is K233744.

When did Curiteva Porous PEEK Lumbar Interbody Fusion System receive FDA 510(k) clearance?

Curiteva Porous PEEK Lumbar Interbody Fusion System received FDA 510(k) clearance on 2024-01-18, under 510(k) number K233744.

Who is the listed applicant for Curiteva Porous PEEK Lumbar Interbody Fusion System?

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

What is the FDA product code for Curiteva Porous PEEK Lumbar Interbody Fusion System?

The FDA product code for Curiteva Porous PEEK Lumbar Interbody Fusion System is MAX.

其他以 Curiteva, 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。

K252205Curiteva多孔PEEK頸椎間板系統；Curiteva多孔PEEK腰椎間板系統；Curiteva多孔PEEK椎板成形系統；Curiteva多孔PEEK獨立ALIF系統 K254061Curiteva多孔PEEK頸椎間融合系統 K250845Curiteva多孔PEEK獨立ALIF系統 K243137Curiteva多孔PEEK椎板成形系統 K233360Curiteva 胸腰椎板系統 K231232Curiteva 樂林術系統

查看所有 11 項裝置 →

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。