CD Horizon™ Astute™ Spinal System

GUDID 00763000312978

PEEK ROD 1608451055 6.0 X 6.9MM STR 55MM

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile
Primary Device ID00763000312978
NIH Device Record Key6da4b179-ea23-4181-998c-d416b9e56c9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCD Horizon™ Astute™ Spinal System
Version Model Number1608451055
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter
Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter
Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter
Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter
Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter
Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter
Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter
Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter
Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter
Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter
Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter
Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter
Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter
Outer Diameter55 Millimeter
Length6 Millimeter
Width6.9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000312978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-24
Device Publish Date2020-08-14

On-Brand Devices [CD Horizon™ Astute™ Spinal System]

00763000313029PEEK ROD 1608451080 6.0 X 6.9MM STR 80MM
00763000312954PEEK ROD 1608451045 6.0 X 6.9MM STR 45MM
00763000312947PEEK ROD 1608451040 6.0 X 6.9MM STR 40MM
00763000312930PEEK ROD 1608451035 6.0 X 6.9MM STR 35MM
00763000312923PEEK ROD 1608451030 6.0 X 6.9MM STR 30MM
00763000312916PEEK ROD 1608451025 6.0 X 6.9MM STR 25MM
00763000313128PEEK ROD 1608451130 6.0X6.9MM STR 130MM
00763000313111PEEK ROD 1608451125 6.0X6.9MM STR 125MM
00763000313104PEEK ROD 1608451120 6.0X6.9MM STR 120MM
00763000313098PEEK ROD 1608451115 6.0X6.9MM STR 115MM
00763000313081PEEK ROD 1608451110 6.0X6.9MM STR 110MM
00763000313074PEEK ROD 1608451105 6.0X6.9MM STR 105MM
00763000313067PEEK ROD 1608451100 6.0X6.9MM STR 100MM
00763000313050PEEK ROD 1608451095 6.0 X 6.9MM STR 95MM
00763000313043PEEK ROD 1608451090 6.0 X 6.9MM STR 90MM
00763000313036PEEK ROD 1608451085 6.0 X 6.9MM STR 85MM
00763000313012PEEK ROD 1608451075 6.0 X 6.9MM STR 75MM
00763000313005PEEK ROD 1608451070 6.0 X 6.9MM STR 70MM
00763000312992PEEK ROD 1608451065 6.0 X 6.9MM STR 65MM
00763000312985PEEK ROD 1608451060 6.0 X 6.9MM STR 60MM
00763000312978PEEK ROD 1608451055 6.0 X 6.9MM STR 55MM
00763000312961PEEK ROD 1608451050 6.0 X 6.9MM STR 50MM
00613994667434SET SCREW 5630724 BRKOFF 6.0PEEK STERBX4
00763000313333SET SCREW 5530620 BREAKOFF 6.0 PEEK STER

Trademark Results [CD Horizon]

Mark Image

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