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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Wright Medical. It received FDA 510(k) clearance on 2021-05-11 under 510(k) 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. The listed applicant is Wright Medical. The 510(k) number is K203228.

When did DART-FIRE EDGE Cannulated Screw System receive FDA 510(k) clearance?

DART-FIRE EDGE Cannulated Screw System received FDA 510(k) clearance on 2021-05-11, under 510(k) number K203228.

Who is the listed applicant for DART-FIRE EDGE Cannulated Screw System?

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

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.

Other records listing Wright Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203832FuseForce™ Flex Dynamic Compression SystemK162033SALVATION External Fixation System

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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