FDA 510(k)

TITAN 3-D™ 鋸齒系統

K 號：K162241 · 2017-04-03

決定日期2017-04-03

產品代碼PLF

諮詢委員會或

決定相當於

器材摘要

TITAN 3-D™ Wedge System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28. It received FDA 510(k) clearance on 2017-04-03 under 510(k) number K162241. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TITAN 3-D™ Wedge System?

TITAN 3-D™ Wedge System is a medical device that received FDA 510(k) clearance on 2017-04-03. The listed applicant is Paragon 28. The 510(k) number is K162241.

When did TITAN 3-D™ Wedge System receive FDA 510(k) clearance?

TITAN 3-D™ Wedge System received FDA 510(k) clearance on 2017-04-03, under 510(k) number K162241.

Who is the listed applicant for TITAN 3-D™ Wedge System?

The FDA 510(k) record lists Paragon 28 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TITAN 3-D™ Wedge System?

The FDA product code for TITAN 3-D™ Wedge System is PLF.

其他以 Paragon 28 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：PLF）

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。

K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC K252254骨切楔形系統Sinaptic Surgical K251791Auxano® 極板固定系統Auxano Medical, LLC K240461OsteoSinter® EVANS 與 COTTON 塊及相關配件Ames Medical Prosthetic Solutions, S.A.U.K243231三角PEEK HA楔子Nvision Biomedical Technologies K234116Trigon Trigon HA 独立楔形固定系統Nvision Biomedical Technologies

官方來源

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