FDA 510(k)

CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System

K-Nummer: K193543 · 2020-01-17

Entscheidungsdatum2020-01-17

ProduktcodeHRS

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating 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 2020-01-17 under 510(k) number K193543. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System?

CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is In2bones USA, LLC. The 510(k) number is K193543.

When did CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System receive FDA 510(k) clearance?

CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System received FDA 510(k) clearance on 2020-01-17, under 510(k) number K193543.

Who is the listed applicant for CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating 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, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System?

The FDA product code for CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System is HRS.

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Offizielle Quelle

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