FDA 510(k)

Ascential IBD PEEKc Spacer

K 號：K161407 · 2016-07-15

決定日期2016-07-15

產品代碼ODP

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器材摘要

Ascential IBD PEEKc Spacer is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Spine. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K161407. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ascential IBD PEEKc Spacer?

Ascential IBD PEEKc Spacer is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Stryker Spine. The 510(k) number is K161407.

When did Ascential IBD PEEKc Spacer receive FDA 510(k) clearance?

Ascential IBD PEEKc Spacer received FDA 510(k) clearance on 2016-07-15, under 510(k) number K161407.

Who is the listed applicant for Ascential IBD PEEKc Spacer?

FDA 510(k) 記錄將 Stryker Spine 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Ascential IBD PEEKc Spacer?

The FDA product code for Ascential IBD PEEKc Spacer is ODP.

其他以 Stryker Spine 為申請人之記錄

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相關器械（代碼：ODP）

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。

K262595VariLift-C 頸椎間融合系統Wenzel Spine, Inc.K262489BluEX 頸椎擴張籠系統L&K BIOMED Co., Ltd.K2530413D籠架頸椎Fims Co., Ltd.K262061Tritanium® C 頸椎前方金層；Tritanium® PL 金層；Tritanium® TL 弯曲後腰金層；Aero® -C 頸椎金層系統；AVS® Anchor-C 頸椎金層系統；AVS® TL PEEK 间隔器；AVS® PL PEEK 间隔器；AVS® Navigator PEEK 间隔器；AVS® AS PEEK 间隔器；Monterey™ AL 間體系統；Aleutian IBF 系統；Cascadia 間體系統；Chesapeake 稳定系統；Sahara 稳定系統；SANTORINI™ 去骨金層系統；MOJAVE 間體系統；VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. 医療間體融合系統C.A. Medical, LLC K260840BluEX 頸椎擴張籠系統L&K BIOMED Co., Ltd.

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