FDA 510(k)

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K 號：K171031 · 2017-07-06

決定日期2017-07-06

產品代碼MAX

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決定相當於

器材摘要

CRESCENT™ Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K171031. 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 CRESCENT™ Spinal System?

CRESCENT™ Spinal System is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K171031.

When did CRESCENT™ Spinal System receive FDA 510(k) clearance?

CRESCENT™ Spinal System received FDA 510(k) clearance on 2017-07-06, under 510(k) number K171031.

Who is the listed applicant for CRESCENT™ Spinal System?

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

What is the FDA product code for CRESCENT™ Spinal System?

The FDA product code for CRESCENT™ Spinal System is MAX.

其他以 Medtronic Sofamor Danek 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。

K212428中心板固定系統 K201267Adaptix Interbody System with Titan nanoLOCK Surface Technology K173125T2 STRATOSPHERE™ 可擴展椎體切除系統 K172199ELEVATE脊椎系統，CAPSTONE PTC脊椎系統，CRESCENT脊椎系統，CRESCENT脊椎系統钛版 K171468FUSE脊椎系統 K170679CD HORIZON®脊椎系統，與IPC® POWEREASE®系統配合使用的Medtronic可重用儀器，與STEALTHSTATION®及IPC® POWEREASE®系統配合使用的Medtronic導航可重用儀器

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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

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