DART-FIRE EDGE Cannulated Screw System
K-Number: K203228 · 2021-05-11
ApplicantWright Medical
Decision Date2021-05-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
DART-FIRE EDGE Cannulated Screw System is a medical device manufactured by Wright Medical. It received FDA 510(k) clearance on 2021-05-11 under approval number K203228. 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 DART-FIRE EDGE Cannulated Screw System?
DART-FIRE EDGE Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2021-05-11. It is manufactured by Wright Medical. The 510(k) number is K203228.
When was DART-FIRE EDGE Cannulated Screw System approved by the FDA?
DART-FIRE EDGE Cannulated Screw System received FDA 510(k) clearance on 2021-05-11, under approval number K203228.
What company makes DART-FIRE EDGE Cannulated Screw System?
DART-FIRE EDGE Cannulated Screw System is manufactured by Wright Medical.
What is the FDA product code for DART-FIRE EDGE Cannulated Screw System?
The FDA product code for DART-FIRE EDGE Cannulated Screw System is HWC. This falls under the Cardiovascular category.
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Official Source
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