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FDA 510(k)

Stryker客製化顎骨重建板；Stryker外科醫師iD顎骨重建板

K 號：K222650 · 2022-12-09

申請人Stryker Craniomaxillofacial (Cmf)
決定日期2022-12-09
產品代碼JEY
諮詢委員會DE
決定相當於

器材摘要

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Craniomaxillofacial (Cmf). It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K222650. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate?

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Stryker Craniomaxillofacial (Cmf). The 510(k) number is K222650.

When did Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate receive FDA 510(k) clearance?

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate received FDA 510(k) clearance on 2022-12-09, under 510(k) number K222650.

Who is the listed applicant for Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate?

The FDA 510(k) record lists Stryker Craniomaxillofacial (Cmf) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate?

The FDA product code for Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate is JEY.

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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相關器械（代碼：JEY）

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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官方來源

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