FDA 510(k)

DePuy Synthes 骨折外傷骨科釘植入體

K 號：K182783 · 2018-12-26

決定日期2018-12-26

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

DePuy Synthes Trauma Orthopedic Nail Implants is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2018-12-26 under 510(k) number K182783. 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 DePuy Synthes Trauma Orthopedic Nail Implants?

DePuy Synthes Trauma Orthopedic Nail Implants is a medical device that received FDA 510(k) clearance on 2018-12-26. The listed applicant is DePuy Synthes. The 510(k) number is K182783.

When did DePuy Synthes Trauma Orthopedic Nail Implants receive FDA 510(k) clearance?

DePuy Synthes Trauma Orthopedic Nail Implants received FDA 510(k) clearance on 2018-12-26, under 510(k) number K182783.

Who is the listed applicant for DePuy Synthes Trauma Orthopedic Nail Implants?

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

What is the FDA product code for DePuy Synthes Trauma Orthopedic Nail Implants?

The FDA product code for DePuy Synthes Trauma Orthopedic Nail Implants is HRS.

其他以 DePuy Synthes 為申請人之記錄

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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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