COLORADO 2™ Spinal System

GUDID 00721902071089

SCREW 8638765 PED D7.5MM L65MM

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00721902071089
NIH Device Record Key6a2cb2b0-4ad2-4f5d-99ea-4962d1b777e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOLORADO 2™ Spinal System
Version Model Number8638765
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 Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter
Length65 Millimeter
Outer Diameter7.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100721902071089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

[00721902071089]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-04

On-Brand Devices [COLORADO 2™ Spinal System]

00613994125354HOOK X335010 06.35 CLOSED LAMINAR
00673978953373STAPLE 8639400 ANTERIOR
00673978953366SCREW 8639300 L AND ILIO L SET
00673978953236CONNECTOR 8635430 LATERAL CLOSED
00673978953212SCREW 8635405 BREAK OFF LOCKING
00673978953205CONNECTOR 8635400 5.5X5.5 LAT CLOSE CLMP
00673978953199CONNECTOR 8634200 OFFSET CLAMP
00673978953168CONNECTOR 8634110 SACRAL ILIO PLATE
00673978953144CLIP 8634100 FOR 5.5MM ROD
006739789529017.5MM SCREW X 60MM
00673978952635SCREW 8632370 CLRD SACRAL 7.0X70MM
00673978952628SCREW 8632365 CLRD SACRAL 7.0X65MM
00673978952611SCREW 8632360 CLRD SACRAL 7.0X60MM
00673978952604SCREW 8632355 CLRD SACRAL 7.0X55MM
00673978952598SCREW 8632350 CLRD SACRAL 7.0X50MM
00673978952581SCREW 8632345 CLRD SACRAL 7.0X45MM
00673978952574SCREW 8632340 CLRD SACRAL 7.0X40MM
00673978952567SCREW 8632335 CLRD SACRAL 7.0X35MM
00673978952550SCREW 8632330 CLRD SACRAL 7.0X30MM
00673978952543SCREW 8632270 CLRD SACRAL 6.5X70MM
00673978952536SCREW 8632265 CLRD SACRAL 6.5X65MM
00673978952529SCREW 8632260 CLRD SACRAL 6.5X60MM
00673978952512SCREW 8632255 CLRD SACRAL 6.5X55MM
00673978952505SCREW 8632250 CLRD SACRAL 6.5X50MM
00673978952499SCREW 8632245 CLRD SACRAL 6.5X45MM
00673978952482SCREW 8632240 CLRD SACRAL 6.5X40MM
00673978952475SCREW 8632235 CLRD SACRAL 6.5X35MM
00673978952468SCREW 8632230 CLRD SACRAL 6.5X30MM
00673978952451SCREW 8632080 CLRD ILIO SACRAL 7.0X80MM
00673978952444SCREW 8632075 CLRD ILIO SACRAL 7.0X75MM
00673978952437SCREW 8632070 CLRD ILIO SACRAL 7.0X70MM
00673978952420SCREW 8632065 CLRD ILIO SACRAL 7.0X65MM
00673978952413SCREW 8632060 CLRD ILIO SACRAL 7.0X60MM
00673978952406SCREW 8632055 CLRD ILIO SACRAL 7.0X55MM
00673978952390SCREW 8632050 CLRD ILIO SACRAL 7.0X50MM
00673978952376HOOK 8631402 CLOSED LAMINAR THORACIC
00673978952369STAPLE 8631300
00673978952352HOOK 8631204 LARGE LAMINAR
00673978952345HOOK 8631203 MEDIUM LAMINAR
00673978952338HOOK 8631202 SMALL LAMINAR
00673978952321HOOK 8631104 LARGE PEDICLE
00673978952314HOOK 8631102 SMALL PEDICLE
00673978952185SCREW 8630650 CLRD 6.5MMX50MM
00673978952178SCREW 8630645 CLRD 6.5MMX45MM
00673978952116SCREW 8630550 CLRD 5.5MMX50MM
00673978952093SCREW 8630540 CLRD 5.5MMX40MM
00673978951959PLATE 8619654 INTERPEDICULAR 54MM
00673978951683CONNECTOR 8614200 OFFSET
00673978951645SCREW 8612230 CLRD SACRAL 6.5X30MM
00673978951515SCREW 8610765 CLRD 7.5MMX65MM
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