4CIS Marlin PEEK ACIF Cage

Intervertebral Fusion Device With Bone Graft, Cervical

Solco Biomedical Co., Ltd.

The following data is part of a premarket notification filed by Solco Biomedical Co., Ltd. with the FDA for 4cis Marlin Peek Acif Cage.

Pre-market Notification Details

• Device ID: K192044
• 510k Number: K192044
• Device Name: 4CIS Marlin PEEK ACIF Cage
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: Solco Biomedical Co., Ltd. 154 Seotan-ro, Seotan-myeon Pyeongtaek-si, KR 17704
• Contact: Hwi-geun Yu
• Correspondent: Hwi-geun Yu; Solco Biomedical Co., Ltd. 154 Seotan-ro, Seotan-myeon Pyeongtaek-si, KR 17704
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-07-31
• Decision Date: 2019-12-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800033348603	K192044	000
08800033348450	K192044	000
08800033348443	K192044	000
08800033348252	K192044	000
08800033348245	K192044	000
08800033348238	K192044	000
08800033348221	K192044	000
08800033348214	K192044	000
08800033348207	K192044	000
08800033348191	K192044	000
08800033348184	K192044	000
08800033348177	K192044	000
08800033348160	K192044	000
08800033348467	K192044	000
08800033348474	K192044	000
08800033348597	K192044	000
08800033348580	K192044	000
08800033348573	K192044	000
08800033348566	K192044	000
08800033348559	K192044	000
08800033348542	K192044	000
08800033348535	K192044	000
08800033348528	K192044	000
08800033348511	K192044	000
08800033348504	K192044	000
08800033348498	K192044	000
08800033348481	K192044	000
08800033348153	K192044	000
08800033348146	K192044	000
08800033347996	K192044	000
08800033347989	K192044	000
08800033347972	K192044	000
08800033347965	K192044	000
08800033347958	K192044	000
08800033347941	K192044	000
08800033347934	K192044	000
08800033347927	K192044	000
08800033347910	K192044	000
08800033347903	K192044	000
08800033347897	K192044	000
08800033347880	K192044	000
08800033348009	K192044	000
08800033348016	K192044	000
08800033348139	K192044	000
08800033348122	K192044	000
08800033348115	K192044	000
08800033348108	K192044	000
08800033348092	K192044	000
08800033348085	K192044	000
08800033348078	K192044	000
08800033348061	K192044	000
08800033348054	K192044	000
08800033348047	K192044	000
08800033348030	K192044	000
08800033348023	K192044	000
08800033347873	K192044	000
08806373584688	K192044	000
08800033349013	K192044	000
08800033349006	K192044	000
08800033348993	K192044	000
08800033348986	K192044	000
08800033348979	K192044	000
08800033348962	K192044	000
08800033348955	K192044	000
08800033348948	K192044	000
08800033348931	K192044	000
08800033348924	K192044	000
08800033348917	K192044	000
08800033348900	K192044	000
08800033349020	K192044	000
08800033349037	K192044	000
08800033349150	K192044	000
08800033349143	K192044	000
08800033349136	K192044	000
08800033349129	K192044	000
08800033349112	K192044	000
08800033349105	K192044	000
08800033349099	K192044	000
08800033349082	K192044	000
08800033349075	K192044	000
08800033349068	K192044	000
08800033349051	K192044	000
08800033349044	K192044	000
08800033348894	K192044	000
08800033348887	K192044	000
08800033348733	K192044	000
08800033348726	K192044	000
08800033348719	K192044	000
08800033348702	K192044	000
08800033348696	K192044	000
08800033348689	K192044	000
08800033348672	K192044	000
08800033348665	K192044	000
08800033348658	K192044	000
08800033348641	K192044	000
08800033348634	K192044	000
08800033348627	K192044	000
08800033348740	K192044	000
08800033348757	K192044	000
08800033348870	K192044	000
08800033348863	K192044	000
08800033348856	K192044	000
08800033348849	K192044	000
08800033348832	K192044	000
08800033348825	K192044	000
08800033348818	K192044	000
08800033348801	K192044	000
08800033348795	K192044	000
08800033348788	K192044	000
08800033348771	K192044	000
08800033348764	K192044	000
08800033348610	K192044	000