Data / Medical devices / South Korea / Megagen Implant Co., Ltd.

Megagen Implant Co., Ltd.: FDA-registered device maker in Daegu, South Korea, 34 510(k) clearances

Megagen Implant Co., Ltd. is registered with the FDA (registration 3005554774) in Daegu, South Korea. It lists 17 device types. The FDA files 34 510(k) clearances under its listings, the newest dated June 18, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number

3005554774

Address

45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu, South Korea, 42921

Owner or operator

MEGAGEN IMPLANT CO. LTD (9067358)

Roles

Exporter to the US, Manufacturer, Repackager or relabeler

First device listed

March 22, 2005

Registered through

2026

Brand names listed

911 Fixture kit, 911kit, AI Surgical Kit, ARi ExCon Implant System, AXA Carrier, AXA Driver, AXA Prosthetic Kit, AXA Scanbody Kit for R2 Photogram and more

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

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Updated June 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.