FDA 510(k)

皮特卡德夫特修系統

K 號：K200728 · 2020-10-06

決定日期2020-10-06

產品代碼KTT

諮詢委員會或

決定相當於

器材摘要

Pitkar DeftFix System is the device name listed in this FDA 510(k) record. The listed applicant is S.H.Pitkar Orthotools Pvt. , Ltd.. It received FDA 510(k) clearance on 2020-10-06 under 510(k) number K200728. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pitkar DeftFix System?

Pitkar DeftFix System is a medical device that received FDA 510(k) clearance on 2020-10-06. The listed applicant is S.H.Pitkar Orthotools Pvt. , Ltd.. The 510(k) number is K200728.

When did Pitkar DeftFix System receive FDA 510(k) clearance?

Pitkar DeftFix System received FDA 510(k) clearance on 2020-10-06, under 510(k) number K200728.

Who is the listed applicant for Pitkar DeftFix System?

The FDA 510(k) record lists S.H.Pitkar Orthotools Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pitkar DeftFix System?

The FDA product code for Pitkar DeftFix System is KTT.

其他以 S.H.Pitkar Orthotools Pvt. , Ltd. 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。

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相關器械（代碼：KTT）

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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