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FDA 510(k)

增材醫學病人專屬3D固定網格板

K 號：K183011 · 2019-01-10

申請人Additive Orthopaedics
決定日期2019-01-10
產品代碼HRS
諮詢委員會或
決定相當於

器材摘要

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates is the device name listed in this FDA 510(k) record. The listed applicant is Additive Orthopaedics. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K183011. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Additive Orthopaedics Patient Specific 3D Locking Lattice Plates?

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Additive Orthopaedics. The 510(k) number is K183011.

When did Additive Orthopaedics Patient Specific 3D Locking Lattice Plates receive FDA 510(k) clearance?

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates received FDA 510(k) clearance on 2019-01-10, under 510(k) number K183011.

Who is the listed applicant for Additive Orthopaedics Patient Specific 3D Locking Lattice Plates?

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

What is the FDA product code for Additive Orthopaedics Patient Specific 3D Locking Lattice Plates?

The FDA product code for Additive Orthopaedics Patient Specific 3D Locking Lattice Plates is HRS.

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：HRS）

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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