FDA 510(k)

Injection Screw

Numéro K : K173556 · 2018-07-13

Date de décision2018-07-13

Code produitHWC

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Injection Screw is the device name listed in this FDA 510(k) record. The listed applicant is Biedermann Medtech, Inc.. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K173556. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Injection Screw?

Injection Screw is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Biedermann Medtech, Inc.. The 510(k) number is K173556.

When did Injection Screw receive FDA 510(k) clearance?

Injection Screw received FDA 510(k) clearance on 2018-07-13, under 510(k) number K173556.

Who is the listed applicant for Injection Screw?

The FDA 510(k) record lists Biedermann Medtech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Injection Screw?

The FDA product code for Injection Screw is HWC. This falls under the Cardiovascular category.

Essais cliniques associés

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Source officielle

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