ARIX Ankle Distal Tibia System

Plate, Fixation, Bone

Jeil Medical Corporation

The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Arix Ankle Distal Tibia System.

Pre-market Notification Details

• Device ID: K202912
• 510k Number: K202912
• Device Name: ARIX Ankle Distal Tibia System
• Classification: Plate, Fixation, Bone
• Applicant: Jeil Medical Corporation 702,703,704,705,706,804,805,807,812,815-ho, 55, Digital-ro 34-gil, Guro-gu Seoul, KR 08378
• Contact: Ahhyeon Woo
• Correspondent: Ahhyeon Woo; Jeil Medical Corporation 702,703,704,705,706,804,805,807,812,815-ho, 55, Digital-ro 34-gil, Guro-gu Seoul, KR 08378
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-09-29
• Decision Date: 2020-10-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800089415182	K202912	000
08800089409075	K202912	000
08800089409068	K202912	000
08800089409051	K202912	000
08800089409044	K202912	000
08800089409037	K202912	000
08800089409020	K202912	000
08800089409013	K202912	000
08800089409006	K202912	000
08800089408993	K202912	000
08800089408986	K202912	000
08800089409082	K202912	000
08800089409099	K202912	000
08800089409105	K202912	000
08800089409204	K202912	000
08800089409198	K202912	000
08800089409181	K202912	000
08800089409174	K202912	000
08800089409167	K202912	000
08800089409150	K202912	000
08800089409143	K202912	000
08800089409136	K202912	000
08800089409129	K202912	000
08800089409112	K202912	000
08800089408979	K202912	000
08800089408962	K202912	000
08800089408955	K202912	000
08800089408818	K202912	000
08800089408801	K202912	000
08800089408795	K202912	000
08800089408788	K202912	000
08800089408771	K202912	000
08800089408764	K202912	000
08800089408757	K202912	000
08800089408740	K202912	000
08800089408733	K202912	000
08800089408726	K202912	000
08800089408825	K202912	000
08800089408832	K202912	000
08800089408849	K202912	000
08800089408948	K202912	000
08800089408931	K202912	000
08800089408924	K202912	000
08800089408917	K202912	000
08800089408900	K202912	000
08800089408894	K202912	000
08800089408887	K202912	000
08800089408870	K202912	000
08800089408863	K202912	000
08800089408856	K202912	000
08800089408719	K202912	000
08800089416134	K202912	000
08806390883467	K202912	000
08806390883320	K202912	000
08806390883313	K202912	000
08806390883306	K202912	000
08806390883290	K202912	000
08806390883283	K202912	000
08806390883221	K202912	000
08800089400294	K202912	000
08800089400287	K202912	000
08800089400270	K202912	000
08800089400263	K202912	000
08806390883337	K202912	000
08806390883344	K202912	000
08806390883351	K202912	000
08806390883450	K202912	000
08806390883443	K202912	000
08806390883436	K202912	000
08806390883429	K202912	000
08806390883412	K202912	000
08806390883405	K202912	000
08806390883399	K202912	000
08806390883382	K202912	000
08806390883375	K202912	000
08806390883368	K202912	000
08800089400256	K202912	000
08800089409716	K202912	000
08800089409709	K202912	000
08800089409563	K202912	000
08800089409556	K202912	000
08800089409549	K202912	000
08800089409532	K202912	000
08800089409525	K202912	000
08800089409518	K202912	000
08800089409501	K202912	000
08800089409495	K202912	000
08800089411597	K202912	000
08800089427253	K202912	000
08800089409570	K202912	000
08800089409587	K202912	000
08800089409594	K202912	000
08800089409693	K202912	000
08800089409686	K202912	000
08800089409679	K202912	000
08800089409662	K202912	000
08800089409655	K202912	000
08800089409648	K202912	000
08800089409631	K202912	000
08800089409624	K202912	000
08800089409617	K202912	000
08800089409600	K202912	000
08800089418176	K202912	000