MODIFICATION TO 4CIS VANE SPINE SYSTEM

Orthosis, Spinal Pedicle Fixation

SOLCO BIOMEDICAL CO., LTD.

The following data is part of a premarket notification filed by Solco Biomedical Co., Ltd. with the FDA for Modification To 4cis Vane Spine System.

Pre-market Notification Details

• Device ID: K081145
• 510k Number: K081145
• Device Name: MODIFICATION TO 4CIS VANE SPINE SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: SOLCO BIOMEDICAL CO., LTD. 155 GIBBS ST., SUITE 512 Rockville, MD 20850
• Contact: Saeyoung Ahn
• Correspondent: Saeyoung Ahn; SOLCO BIOMEDICAL CO., LTD. 155 GIBBS ST., SUITE 512 Rockville, MD 20850
• Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-04-22
• Decision Date: 2008-11-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08806373521621	K081145	000
08806373564079	K081145	000
08806373566202	K081145	000
08806373566332	K081145	000
08806373566356	K081145	000
08806373566493	K081145	000
08806373566509	K081145	000
08806373566639	K081145	000
08806373566646	K081145	000
08806373566653	K081145	000
08806373566684	K081145	000
08806373566721	K081145	000
08806373566738	K081145	000
08806373566745	K081145	000
08806373566776	K081145	000
08806373566783	K081145	000
08806373566790	K081145	000
08806373551932	K081145	000
08806373545221	K081145	000
08806373521638	K081145	000
08806373521645	K081145	000
08806373521652	K081145	000
08806373521782	K081145	000
08806373521836	K081145	000
08806373521843	K081145	000
08806373524783	K081145	000
08806373524790	K081145	000
08806373524806	K081145	000
08806373524813	K081145	000
08806373539275	K081145	000
08806373539282	K081145	000
08806373539299	K081145	000
08806373544958	K081145	000
08806373544965	K081145	000
08806373545122	K081145	000
08806373567919	K081145	000
08806373568046	K081145	000
08806373571985	K081145	000
08806373571992	K081145	000
08806373572005	K081145	000
08806373572012	K081145	000
08806373572029	K081145	000
08806373572043	K081145	000
08806373572067	K081145	000
08806373572081	K081145	000
08806373573040	K081145	000
08806373573057	K081145	000
08806373573064	K081145	000
08806373573071	K081145	000
08806373573088	K081145	000
08806373573095	K081145	000
08806373573101	K081145	000
08806373577116	K081145	000
08806373571978	K081145	000
08806373571961	K081145	000
08806373568169	K081145	000
08806373569845	K081145	000
08806373570193	K081145	000
08806373570209	K081145	000
08806373570216	K081145	000
08806373571770	K081145	000
08806373571787	K081145	000
08806373571794	K081145	000
08806373571800	K081145	000
08806373571824	K081145	000
08806373571893	K081145	000
08806373571909	K081145	000
08806373571916	K081145	000
08806373571930	K081145	000
08806373571947	K081145	000
08806373571954	K081145	000
08806373590382	K081145	000