PREMIER(TM) Anterior Cervical Plate System

GUDID 00721902710513

PLATE 6861182 82.5MM ANTERIOR CERVICAL

MEDTRONIC SOFAMOR DANEK, INC.

Spinal fixation plate, non-bioabsorbable

Primary Device ID	00721902710513
NIH Device Record Key	5d605089-edff-4916-886b-c1b110dcfcf8
Commercial Distribution Status	In Commercial Distribution
Brand Name	PREMIER(TM) Anterior Cervical Plate System
Version Model Number	6861182
Company DUNS	830350380
Company Name	MEDTRONIC SOFAMOR DANEK, 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(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Dimensions

Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter
Width	82.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902710513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K021761

FDA Product Code

KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY