Panels › Orthopedic › Product code ODP · Class 2

Intervertebral Fusion Device With Bone Graft, Cervical

Regulation 888.3080

24510(k)s in 12 months (354 all time)

2recalls in 12 months (11 all time)

9recalls that name a 510(k)

Top companies in ODP

Company	510(k)s	Recalls
Medtronic Sofamor Danek	10	0
Orthofix	10	0
Nu Vasive, Incorporated	8	0
Gbs Commonwealth Co., Ltd.	7	0
Globus Medical, Inc.	7	0
Reliance Medical Systems, LLC	6	0
Spineart	6	0
Stryker Spine	6	0
Innovasis, Inc.	5	0
L&K BIOMED Co., Ltd.	5	0

Decided	510(k)	Device and applicant	Code
Sep 5, 2008	K081614	ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES Interbody Innovations, Llp	ODP
Feb 7, 2008	K073320	CIMPLICITY SPINAL SYSTEM Spine Smith Partners L.P.	ODP
Jan 24, 2008	K073351	CRYSTAL Spinal Elements, Inc.	ODP
Jan 18, 2008	K072991	PATRIOT SPACERS: COLONIAL ACDF Globus Medical, Inc.	ODP

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