COLORADO 2™ Spinal System

GUDID 00613994125354

HOOK X335010 06.35 CLOSED LAMINAR

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00613994125354
• NIH Device Record Key: 60e5b0b7-4248-43b7-afc7-19e2308591cf
• Commercial Distribution Discontinuation: 2018-10-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: COLORADO 2™ Spinal System
• Version Model Number: X335010
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994125354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991031

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00613994125354]

Moist Heat or Steam Sterilization

[00613994125354]

Moist Heat or Steam Sterilization

[00613994125354]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-29
• Device Publish Date: 2015-08-19

On-Brand Devices [COLORADO 2™ Spinal System]

• 00613994125354: HOOK X335010 06.35 CLOSED LAMINAR
• 00673978953373: STAPLE 8639400 ANTERIOR
• 00673978953366: SCREW 8639300 L AND ILIO L SET
• 00673978953236: CONNECTOR 8635430 LATERAL CLOSED
• 00673978953212: SCREW 8635405 BREAK OFF LOCKING
• 00673978953205: CONNECTOR 8635400 5.5X5.5 LAT CLOSE CLMP
• 00673978953199: CONNECTOR 8634200 OFFSET CLAMP
• 00673978953168: CONNECTOR 8634110 SACRAL ILIO PLATE
• 00673978953144: CLIP 8634100 FOR 5.5MM ROD
• 00673978952901: 7.5MM SCREW X 60MM
• 00673978952635: SCREW 8632370 CLRD SACRAL 7.0X70MM
• 00673978952628: SCREW 8632365 CLRD SACRAL 7.0X65MM
• 00673978952611: SCREW 8632360 CLRD SACRAL 7.0X60MM
• 00673978952604: SCREW 8632355 CLRD SACRAL 7.0X55MM
• 00673978952598: SCREW 8632350 CLRD SACRAL 7.0X50MM
• 00673978952581: SCREW 8632345 CLRD SACRAL 7.0X45MM
• 00673978952574: SCREW 8632340 CLRD SACRAL 7.0X40MM
• 00673978952567: SCREW 8632335 CLRD SACRAL 7.0X35MM
• 00673978952550: SCREW 8632330 CLRD SACRAL 7.0X30MM
• 00673978952543: SCREW 8632270 CLRD SACRAL 6.5X70MM
• 00673978952536: SCREW 8632265 CLRD SACRAL 6.5X65MM
• 00673978952529: SCREW 8632260 CLRD SACRAL 6.5X60MM
• 00673978952512: SCREW 8632255 CLRD SACRAL 6.5X55MM
• 00673978952505: SCREW 8632250 CLRD SACRAL 6.5X50MM
• 00673978952499: SCREW 8632245 CLRD SACRAL 6.5X45MM
• 00673978952482: SCREW 8632240 CLRD SACRAL 6.5X40MM
• 00673978952475: SCREW 8632235 CLRD SACRAL 6.5X35MM
• 00673978952468: SCREW 8632230 CLRD SACRAL 6.5X30MM
• 00673978952451: SCREW 8632080 CLRD ILIO SACRAL 7.0X80MM
• 00673978952444: SCREW 8632075 CLRD ILIO SACRAL 7.0X75MM
• 00673978952437: SCREW 8632070 CLRD ILIO SACRAL 7.0X70MM
• 00673978952420: SCREW 8632065 CLRD ILIO SACRAL 7.0X65MM
• 00673978952413: SCREW 8632060 CLRD ILIO SACRAL 7.0X60MM
• 00673978952406: SCREW 8632055 CLRD ILIO SACRAL 7.0X55MM
• 00673978952390: SCREW 8632050 CLRD ILIO SACRAL 7.0X50MM
• 00673978952376: HOOK 8631402 CLOSED LAMINAR THORACIC
• 00673978952369: STAPLE 8631300
• 00673978952352: HOOK 8631204 LARGE LAMINAR
• 00673978952345: HOOK 8631203 MEDIUM LAMINAR
• 00673978952338: HOOK 8631202 SMALL LAMINAR
• 00673978952321: HOOK 8631104 LARGE PEDICLE
• 00673978952314: HOOK 8631102 SMALL PEDICLE
• 00673978952185: SCREW 8630650 CLRD 6.5MMX50MM
• 00673978952178: SCREW 8630645 CLRD 6.5MMX45MM
• 00673978952116: SCREW 8630550 CLRD 5.5MMX50MM
• 00673978952093: SCREW 8630540 CLRD 5.5MMX40MM
• 00673978951959: PLATE 8619654 INTERPEDICULAR 54MM
• 00673978951683: CONNECTOR 8614200 OFFSET
• 00673978951645: SCREW 8612230 CLRD SACRAL 6.5X30MM
• 00673978951515: SCREW 8610765 CLRD 7.5MMX65MM