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FDA 510(k)

StageOne Select Cement Spacer Molds for Temporary Hip Replacement

K 號：K161166 · 2016-09-08

申請人Biomet, Inc.
決定日期2016-09-08
產品代碼MBB
諮詢委員會OR
決定Substantially Equivalent

器材摘要

StageOne Select Cement Spacer Molds for Temporary Hip Replacement is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K161166. The device is classified under product code MBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the StageOne Select Cement Spacer Molds for Temporary Hip Replacement?

StageOne Select Cement Spacer Molds for Temporary Hip Replacement is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Biomet, Inc.. The 510(k) number is K161166.

When did StageOne Select Cement Spacer Molds for Temporary Hip Replacement receive FDA 510(k) clearance?

StageOne Select Cement Spacer Molds for Temporary Hip Replacement received FDA 510(k) clearance on 2016-09-08, under 510(k) number K161166.

Who is the listed applicant for StageOne Select Cement Spacer Molds for Temporary Hip Replacement?

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

What is the FDA product code for StageOne Select Cement Spacer Molds for Temporary Hip Replacement?

The FDA product code for StageOne Select Cement Spacer Molds for Temporary Hip Replacement is MBB.

相關臨床試驗

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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其他以 Biomet, 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。

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

查看所有 36 項裝置 →

相關器械（代碼：MBB）

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。

K252443SpaceFix Shoulder SpacerG21, S.R.L.K242216GENTAFIX® (1, 3, 3MV)Teknimed SasK240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbHK222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc.K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.K213287StageOne Knee Cement Spacer MoldsBiomet, Inc.

官方來源

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