FDA 510(k)

NeoFuse HA 高強化 PLIF/TLIF

K 號：K153615 · 2016-05-06

決定日期2016-05-06

產品代碼MAX

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決定相當於

器材摘要

NeoFuse HA Enhanced PLIF/TLIF is the device name listed in this FDA 510(k) record. The listed applicant is Ht Medical, LLC. It received FDA 510(k) clearance on 2016-05-06 under 510(k) number K153615. 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 NeoFuse HA Enhanced PLIF/TLIF?

NeoFuse HA Enhanced PLIF/TLIF is a medical device that received FDA 510(k) clearance on 2016-05-06. The listed applicant is Ht Medical, LLC. The 510(k) number is K153615.

When did NeoFuse HA Enhanced PLIF/TLIF receive FDA 510(k) clearance?

NeoFuse HA Enhanced PLIF/TLIF received FDA 510(k) clearance on 2016-05-06, under 510(k) number K153615.

Who is the listed applicant for NeoFuse HA Enhanced PLIF/TLIF?

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

What is the FDA product code for NeoFuse HA Enhanced PLIF/TLIF?

The FDA product code for NeoFuse HA Enhanced PLIF/TLIF is MAX.

其他以 Ht Medical, LLC 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。

K170318NeoFuse Ti3D PLIF/TLIF/頸椎間核融合器 K170511NeoFuse HA 高強化 PLIF/TLIF

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。

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