CD HORIZON® ASTUTE™ SPINAL SYSTEM

GUDID 00643169281264

PEEK ROD 1608451090 6.0 X 6.9MM STR 90MM

MEDTRONIC SOFAMOR DANEK, INC.

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Primary Device ID	00643169281264
NIH Device Record Key	8c3de34d-1a55-41c3-99fd-565383a99ecc
Commercial Distribution Status	In Commercial Distribution
Brand Name	CD HORIZON® ASTUTE™ SPINAL SYSTEM
Version Model Number	1608451090
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169281264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191066

FDA Product Code

KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-10
Device Publish Date	2024-05-02

On-Brand Devices [CD HORIZON® ASTUTE™ SPINAL SYSTEM]

00643169281264	PEEK ROD 1608451090 6.0 X 6.9MM STR 90MM
00643169281110	PEEK ROD 1608451035 6.0 X 6.9MM STR 35MM
00643169281165	PEEK ROD 1608451070 6.0 X 6.9MM STR 70MM

Trademark Results [CD HORIZON]

Mark Image Registration \| Serial	Company Trademark Application Date
CD HORIZON 75079759 2108361 Live/Registered	WARSAW ORTHOPEDIC, INC. 1996-03-28