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FDA 510(k)

Syntorr K針及釘系統

K 號:K161489 · 2016-09-16

申請人Syntorr, Inc.
決定日期2016-09-16
產品代碼HTY
諮詢委員會或
決定相當於

器材摘要

Syntorr K-wire and Pin System is the device name listed in this FDA 510(k) record. The listed applicant is Syntorr, Inc.. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K161489. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Syntorr K-wire and Pin System?

Syntorr K-wire and Pin System is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Syntorr, Inc.. The 510(k) number is K161489.

When did Syntorr K-wire and Pin System receive FDA 510(k) clearance?

Syntorr K-wire and Pin System received FDA 510(k) clearance on 2016-09-16, under 510(k) number K161489.

Who is the listed applicant for Syntorr K-wire and Pin System?

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

What is the FDA product code for Syntorr K-wire and Pin System?

The FDA product code for Syntorr K-wire and Pin System is HTY.

相關臨床試驗

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相關器械(代碼:HTY)

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。

官方來源

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