SPACEVISION CAGE SYSTEM

Spinal Vertebral Body Replacement Device

SPINEVISION, INC.

The following data is part of a premarket notification filed by Spinevision, Inc. with the FDA for Spacevision Cage System.

Pre-market Notification Details

• Device ID: K042930
• 510k Number: K042930
• Device Name: SPACEVISION CAGE SYSTEM
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: SPINEVISION, INC. 3003 SUMMIT BLVD. STE 1400 Atlanta, GA 30319
• Contact: Lynette Whitaker
• Correspondent: Lynette Whitaker; SPINEVISION, INC. 3003 SUMMIT BLVD. STE 1400 Atlanta, GA 30319
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-10-22
• Decision Date: 2004-12-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03663136011523	K042930	000
03663136011677	K042930	000
03663136011684	K042930	000
03663136011691	K042930	000
03663136011707	K042930	000
03663136011714	K042930	000
03663136011721	K042930	000
03663136011738	K042930	000
03663136011745	K042930	000
03663136011752	K042930	000
03663136011769	K042930	000
03663136011776	K042930	000
03663136011660	K042930	000
03663136011653	K042930	000
03663136011646	K042930	000
03663136011530	K042930	000
03663136011547	K042930	000
03663136011554	K042930	000
03663136011561	K042930	000
03663136011578	K042930	000
03663136011585	K042930	000
03663136011592	K042930	000
03663136011608	K042930	000
03663136011615	K042930	000
03663136011622	K042930	000
03663136011639	K042930	000
03663136011783	K042930	000
03663136011790	K042930	000
03663136011806	K042930	000
03663136013213	K042930	000
03663136013220	K042930	000
03663136013237	K042930	000
03663136013244	K042930	000
03663136013251	K042930	000
03663136013268	K042930	000
03663136013275	K042930	000
03663136013282	K042930	000
03663136020198	K042930	000
03663136020204	K042930	000
03663136020211	K042930	000
03663136011974	K042930	000
03663136011967	K042930	000
03663136011950	K042930	000
03663136011813	K042930	000
03663136011820	K042930	000
03663136011837	K042930	000
03663136011844	K042930	000
03663136011851	K042930	000
03663136011868	K042930	000
03663136011905	K042930	000
03663136011912	K042930	000
03663136011929	K042930	000
03663136011936	K042930	000
03663136011943	K042930	000
03663136020228	K042930	000