ARI™ Anterior Staple System 1801-D2418R

GUDID 10888857025189

Dual Hole Staple (Right)

K2M, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	10888857025189
NIH Device Record Key	20ee1690-048d-4135-a84d-9cc725e65ce0
Commercial Distribution Status	In Commercial Distribution
Brand Name	ARI™ Anterior Staple System
Version Model Number	1801-D2418R
Catalog Number	1801-D2418R
Company DUNS	146060863
Company Name	K2M, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(703)777-3155
Email	sgilbert@k2m.com
Phone	+1(703)777-3155
Email	sgilbert@k2m.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com
Phone	+1(571)919-2000
Email	mark.zellers@stryker.com

Device Dimensions

Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter
Width	18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857025189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K100851

FDA Product Code

MNI	ORTHOSIS, SPINAL PEDICLE FIXATION