FDA 510(k)

HemiCAP MTP表面磨削半關節成形系統

K 號：K152454 · 2016-04-11

決定日期2016-04-11

產品代碼KWD

諮詢委員會或

決定相當於

器材摘要

HemiCAP MTP Resurfacing Hemi-Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2016-04-11 under 510(k) number K152454. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HemiCAP MTP Resurfacing Hemi-Arthroplasty System?

HemiCAP MTP Resurfacing Hemi-Arthroplasty System is a medical device that received FDA 510(k) clearance on 2016-04-11. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K152454.

When did HemiCAP MTP Resurfacing Hemi-Arthroplasty System receive FDA 510(k) clearance?

HemiCAP MTP Resurfacing Hemi-Arthroplasty System received FDA 510(k) clearance on 2016-04-11, under 510(k) number K152454.

Who is the listed applicant for HemiCAP MTP Resurfacing Hemi-Arthroplasty System?

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

What is the FDA product code for HemiCAP MTP Resurfacing Hemi-Arthroplasty System?

The FDA product code for HemiCAP MTP Resurfacing Hemi-Arthroplasty System is KWD.

其他以 Arthrosurface, 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。

K203375OVOMotion 頸關節翻轉人工關節系統 K200718Arthrosurface WristMotion 總腕關節置换系統 K190261BOSS腳趾固定系統 K181280膝蓋-股骨波（Kahuna）關節成形系統 K173964OVOMotion 肩關節置換系統 K172383Arthrosurface 骨螺釘

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相關器械（代碼：KWD）

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。

K250074HYALEX® MTP 半關節成形術植入體Hyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220蒙羅斯 extremity 医療半植入系統Montross Extremity Medical K222964生物多樂小趾半關節成形術植入體BioPoly, LLC K201393restor3d MTP植入體Restor3D, Inc.K203634生物多全趾半關節成形術植入體BioPoly, LLC

官方來源

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