FDA 510(k)

織錦生物整合植入體

K 號：K220867 · 2022-05-23

決定日期2022-05-23

產品代碼OWY

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Tapestry Biointegrative Implant is the device name listed in this FDA 510(k) record. The listed applicant is Embody, Inc.. It received FDA 510(k) clearance on 2022-05-23 under 510(k) number K220867. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tapestry Biointegrative Implant?

Tapestry Biointegrative Implant is a medical device that received FDA 510(k) clearance on 2022-05-23. The listed applicant is Embody, Inc.. The 510(k) number is K220867.

When did Tapestry Biointegrative Implant receive FDA 510(k) clearance?

Tapestry Biointegrative Implant received FDA 510(k) clearance on 2022-05-23, under 510(k) number K220867.

Who is the listed applicant for Tapestry Biointegrative Implant?

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

What is the FDA product code for Tapestry Biointegrative Implant?

The FDA product code for Tapestry Biointegrative Implant is OWY.

其他以 Embody, Inc. 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。

K252647織錦生物整合植入體 K223822ACTIVBRAID™K213958生物可吸收夾子 K212306織錦生物整合植入體 K201572TAPESTRY 生物整合植入體

相關器械（代碼：OWY）

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。

K251690Arthrex SpeedFLEX™ 假體Arthrex, Inc.K252647織錦生物整合植入體Embody, Inc.K250109TYBR 膠原膠Tybr Health K243843腱保護器（50242）Kerecis Limited K242631REGENETEN™ 生物誘導植入體Smith & Nephew Inc., Endoscopy Div.K222501再生生物導引式植入體Smith and Nephew, Inc.

官方來源

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