CD HORIZON ESSENCE™ Spinal System

GUDID 00643169428720

SCREW 45440006540 ESSENCE MAS 6.5X40

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00643169428720
NIH Device Record Key4ffb2786-07dc-4d99-9776-00546fa68a1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCD HORIZON ESSENCE™ Spinal System
Version Model Number45440006540
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
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter
Outer Diameter6.5 Millimeter
Length40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169428720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


[00643169428720]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-26
Device Publish Date2019-01-26

On-Brand Devices [CD HORIZON ESSENCE™ Spinal System]

00643169428898SET SCREW 4540020 ESSENCE BREAK-OFF
00643169428812SCREW 45440004540 ESSENCE MAS 4.5X40
00643169428775SCREW 45440005540 ESSENCE MAS 5.5X40
00643169428751SCREW 45440005550 ESSENCE MAS 5.5X50
00643169428720SCREW 45440006540 ESSENCE MAS 6.5X40
00643169428676SCREW 45440007540 ESSENCE MAS 7.5X40
00643169428645SCREW 45440008560 ESSENCE MAS 8.5X60
00643169428560SCREW 45410005540 ESSENCE FAS 5.5X40
00643169428836SCREW 45440004520 ESSENCE MAS 4.5X20
00763000802134SET SCREW 4540020 ESSENCE BREAK-OFF
00763000794682SCREW 45440004520 ESSENCE MAS 4.5X20
00763000794668SCREW 45440004540 ESSENCE MAS 4.5X40
00763000794620SCREW 45440005540 ESSENCE MAS 5.5X40
00763000794606SCREW 45440005550 ESSENCE MAS 5.5X50
00763000794576SCREW 45440006540 ESSENCE MAS 6.5X40
00763000794521SCREW 45440007540 ESSENCE MAS 7.5X40
00763000794491SCREW 45440008560 ESSENCE MAS 8.5X60

Trademark Results [CD HORIZON ESSENCE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CD HORIZON ESSENCE
CD HORIZON ESSENCE
86265903 not registered Dead/Abandoned
Warsaw Orthopedic, Inc.
2014-04-29

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