PROstep(TM) MIS 5mm Chamfer Screw System
K-Number: K221645 · 2023-02-17
ApplicantWright Medical Technology
Decision Date2023-02-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PROstep(TM) MIS 5mm Chamfer Screw System is a medical device manufactured by Wright Medical Technology. It received FDA 510(k) clearance on 2023-02-17 under approval number K221645. 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.
Frequently Asked Questions
What is the PROstep(TM) MIS 5mm Chamfer Screw System?
PROstep(TM) MIS 5mm Chamfer Screw System is a medical device that received FDA 510(k) clearance on 2023-02-17. It is manufactured by Wright Medical Technology. The 510(k) number is K221645.
When was PROstep(TM) MIS 5mm Chamfer Screw System approved by the FDA?
PROstep(TM) MIS 5mm Chamfer Screw System received FDA 510(k) clearance on 2023-02-17, under approval number K221645.
What company makes PROstep(TM) MIS 5mm Chamfer Screw System?
PROstep(TM) MIS 5mm Chamfer Screw System is manufactured by Wright Medical Technology.
What is the FDA product code for PROstep(TM) MIS 5mm Chamfer Screw System?
The FDA product code for PROstep(TM) MIS 5mm Chamfer Screw System is HWC. This falls under the Cardiovascular category.
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Official Source
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