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FDA 510(k)

NuVasive® CoRoent® Small Interlock™ System

K 號：K161442 · 2016-09-28

申請人Nu Vasive, Incorporated
決定日期2016-09-28
產品代碼OVE
諮詢委員會OR
決定Substantially Equivalent

器材摘要

NuVasive® CoRoent® Small Interlock™ System is the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2016-09-28 under 510(k) number K161442. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NuVasive® CoRoent® Small Interlock™ System?

NuVasive® CoRoent® Small Interlock™ System is a medical device that received FDA 510(k) clearance on 2016-09-28. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K161442.

When did NuVasive® CoRoent® Small Interlock™ System receive FDA 510(k) clearance?

NuVasive® CoRoent® Small Interlock™ System received FDA 510(k) clearance on 2016-09-28, under 510(k) number K161442.

Who is the listed applicant for NuVasive® CoRoent® Small Interlock™ System?

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

What is the FDA product code for NuVasive® CoRoent® Small Interlock™ System?

The FDA product code for NuVasive® CoRoent® Small Interlock™ System is OVE.

相關臨床試驗

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其他以 Nu Vasive, Incorporated 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。

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相關器械（代碼：OVE）

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。

K263049SABER-C SystemElevation SpineK261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLCK261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.

官方來源

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