FDA 510(k)

CoLink NeoFuse MIS Plating System (see attached parts list)

Numéro K : K241387 · 2024-08-13

Date de décision2024-08-13

Code produitHRS

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

CoLink NeoFuse MIS Plating System (see attached parts list) is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241387. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CoLink NeoFuse MIS Plating System (see attached parts list)?

CoLink NeoFuse MIS Plating System (see attached parts list) is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is In2bones USA. The 510(k) number is K241387.

When did CoLink NeoFuse MIS Plating System (see attached parts list) receive FDA 510(k) clearance?

CoLink NeoFuse MIS Plating System (see attached parts list) received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241387.

Who is the listed applicant for CoLink NeoFuse MIS Plating System (see attached parts list)?

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

What is the FDA product code for CoLink NeoFuse MIS Plating System (see attached parts list)?

The FDA product code for CoLink NeoFuse MIS Plating System (see attached parts list) is HRS.

Essais cliniques associés

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Source officielle

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