FDA 510(k)

OsteoFab 患者專屬頭蓋設備

K 號：K180064 · 2018-07-27

決定日期2018-07-27

產品代碼GXN

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

OsteoFab Patient Specific Cranial Device is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Performance Materials, Inc.. It received FDA 510(k) clearance on 2018-07-27 under 510(k) number K180064. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OsteoFab Patient Specific Cranial Device?

OsteoFab Patient Specific Cranial Device is a medical device that received FDA 510(k) clearance on 2018-07-27. The listed applicant is Oxford Performance Materials, Inc.. The 510(k) number is K180064.

When did OsteoFab Patient Specific Cranial Device receive FDA 510(k) clearance?

OsteoFab Patient Specific Cranial Device received FDA 510(k) clearance on 2018-07-27, under 510(k) number K180064.

Who is the listed applicant for OsteoFab Patient Specific Cranial Device?

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

What is the FDA product code for OsteoFab Patient Specific Cranial Device?

The FDA product code for OsteoFab Patient Specific Cranial Device is GXN.

其他以 Oxford Performance Materials, Inc. 為申請人之記錄

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K190915骨維坊縫合釘 K161052骨質創造患者專屬臉部設備

相關器械（代碼：GXN）

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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