AnyPlus® Cervical PEEK Cage System

Intervertebral Fusion Device With Bone Graft, Cervical

GS Medical Co., Ltd.

The following data is part of a premarket notification filed by Gs Medical Co., Ltd. with the FDA for Anyplus® Cervical Peek Cage System.

Pre-market Notification Details

• Device ID: K153517
• 510k Number: K153517
• Device Name: AnyPlus® Cervical PEEK Cage System
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: GS Medical Co., Ltd. 90, Osongsaengmyeong 4-ro Osong-eup, Cheongwon-gun, KR 363-951
• Contact: Milan George
• Correspondent: Barry E. Sands; RQMIS Inc. 29 Water Street, Suite 305 Newburyport, MA 01950
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-12-08
• Decision Date: 2016-06-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08806395435838	K153517	000
08806378344836	K153517	000
08806378344829	K153517	000
08806378344812	K153517	000
08806378344805	K153517	000
08806378344799	K153517	000
08806378344782	K153517	000
08806378344775	K153517	000
08806162106497	K153517	000
08806162106480	K153517	000
08806162106473	K153517	000
08806162106466	K153517	000
08806162106459	K153517	000
08806162106442	K153517	000
08806162106435	K153517	000
08806378344843	K153517	000
08806395424979	K153517	000
08806395435821	K153517	000
08806395435814	K153517	000
08806395435807	K153517	000
08806395435791	K153517	000
08806395435784	K153517	000
08806395435777	K153517	000
08806395435760	K153517	000
08806395435692	K153517	000
08806395435685	K153517	000
08806395435678	K153517	000
08806395435661	K153517	000
08806395435654	K153517	000
08806395435647	K153517	000
08806395424986	K153517	000
08806162106428	K153517	000