FDA 510(k)

CoLink植片系統，骨折及矯正系統，RTS植入系統，NeoSpan壓縮釘系統

K 號：K190385 · 2019-08-08

決定日期2019-08-08

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2019-08-08 under 510(k) number K190385. 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 CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System?

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System is a medical device that received FDA 510(k) clearance on 2019-08-08. The listed applicant is In2bones USA, LLC. The 510(k) number is K190385.

When did CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System receive FDA 510(k) clearance?

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System received FDA 510(k) clearance on 2019-08-08, under 510(k) number K190385.

Who is the listed applicant for CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System?

The FDA product code for CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System is HRS.

其他以 In2bones USA, LLC 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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