CD® Spinal System

GUDID 00721902575327

SCREW 8655640 CDH 5.5 TULIP 6MMX40MM ASY

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00721902575327
NIH Device Record Keybcd3123d-9e74-47b5-a72a-3c2e025adb80
Commercial Distribution StatusIn Commercial Distribution
Brand NameCD® Spinal System
Version Model Number8655640
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100721902575327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


[00721902575327]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-31

On-Brand Devices [CD® Spinal System]

00721902575372SCREW 8655750 CDH 5.5 TULIP 7MMX50MM ASY
00721902575358SCREW 8655745 CDH 5.5 TULIP 7MMX45MM ASY
00721902575341SCREW 8655740 CDH 5.5 TULIP 7MMX40MM ASY
00721902575334SCREW 8655645 CDH 5.5 TULIP 6MMX45MM ASY
00721902575327SCREW 8655640 CDH 5.5 TULIP 6MMX40MM ASY
00721902575280SCREW 8655635 CDH 5.5 TULIP 6MMX35MM ASY
00721902575273SCREW 8655545 CDH 5.5 TULIP 5MMX45MM ASY
00721902575259SCREW 8655540 CDH 5.5 TULIP 5MMX40MM ASY
00721902575242SCREW 8655535 CDH 5.5 TULIP 5MMX35MM ASY

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