Panels › Orthopedic › Product code OVD · Class 2

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Regulation 888.3080

9510(k)s in 12 months (205 all time)

2recalls in 12 months (36 all time)

36recalls that name a 510(k)

Top companies in OVD

Company	510(k)s	Recalls
Medtronic Sofamor Danek	6	8
Globus Medical, Inc.	11	0
Nu Vasive, Incorporated	10	0
Biomet Spine	4	4
K2m	7	0
Medacta International	7	0
Alphatec Spine	5	1
Medacta Usa Inc	0	6
Acuity Surgical Devices, LLC	3	2
Renovis Surgical Technologies	5	0

Decided	510(k)	Device and applicant	Code
Jul 2, 2008	K080822	VU APOD INTERVERTABRAL BODY FUSION DEVICE Theken Spine, LLC	OVD
Jun 25, 2008	K081395	SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM Biomet Spine	OVD
Jun 4, 2008	K073109	STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM Surgicraft , Ltd.	OVD
Oct 12, 2007	K072253	SYNFIX-LR SPACER Synthes Spine Co.Lp	OVD
Sep 18, 2007	K071922	INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC Rsb Spine, LLC	OVD

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