INFINITY™ Occipitocervical Upper Thoracic System

GUDID 00643169541887

MULTI AXIAL SCREW 3604538 4.5 X 38MM

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00643169541887
• NIH Device Record Key: a91199ec-ed68-4b62-b34f-a26a143466d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFINITY™ Occipitocervical Upper Thoracic System
• Version Model Number: 3604538
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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 Dimensions

• Device Size Text, specify: 0
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169541887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163375

FDA Product Code

• NKG: Orthosis, cervical pedicle screw spinal fixation

Sterilization

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

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

[00643169541887]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-11
• Device Publish Date: 2018-06-10

On-Brand Devices [INFINITY™ Occipitocervical Upper Thoracic System]

• 00643169839656: CADDY LID 3607035 CT MODULE DOMINO
• 00643169839649: CADDY 3607034 CT MODULE DOMINO
• 00643169839632: CADDY LID 3607033 CT MODULE 4.0MM MAS
• 00643169839625: CADDY 3607032 CT MODULE 4.0MM MAS
• 00643169839618: CADDY LID 3607031 CT MODULE 3.5MM MAS
• 00643169839601: CADDY 3607030 CT MODULE 3.5MM MAS
• 00643169839595: TRAY 3607029 CT MODULE IMPLANT 2 OF 2
• 00643169839588: TRAY 3607028 CT MODULE IMPLANT 1 OF 2
• 00643169839571: TRAY 3607026 COMPLEX INSTRUMENT
• 00643169839564: CADDY LID 3607024 C3-C7 MODULE PRCT ROD
• 00643169839557: CADDY 3607023 C3-C7 MODULE PRECUT ROD
• 00643169839540: CADDY LID 3607022 C3-C7 MODULE SET SCRW
• 00643169839533: CADDY 3607021 C3-C7 MODULE SET SCREW
• 00643169839526: CADDY LID 3607020 C3-C7 MODULE CONNECTR
• 00643169839519: CADDY 3607019 C3-C7 MODULE CONNECTOR
• 00643169839502: CADDY LID 3607018 C3-C7 MODULE 4.0M MAS
• 00643169839496: CADDY 3607017 C3-C7 MODULE 4.0MM MAS
• 00643169839489: CADDY LID 3607016 C3-C7 MODULE 3.5M MAS
• 00643169839472: CADDY 3607015 C3-C7 MODULE 3.5MM MAS
• 00643169839465: TRAY 3607014 C3-C7 IMPLANT 2 OF 2
• 00643169839458: TRAY 3607013 C3-C7 IMPLANT 1 OF 2
• 00643169839441: TRAY 3607011 C3-C7 INSTRUMENT 2 OF 2
• 00643169839434: TRAY 3607010 C3-C7 INSTRUMENT 1 OF 2
• 00643169839427: CADDY LID 3607008 OC PLATE AND SCRW CONN
• 00643169839410: CADDY 3607007 OC PLATE AND SCREW CONN
• 00643169839403: CADDY LID 3607006 OC SCREW
• 00643169839397: CADDY 3607005 OC SCREW
• 00643169839380: CADDY LID 3607004 OC-C2 MODULE MAS
• 00643169839373: CADDY 3607003 OC-C2 MODULE MAS
• 00643169839366: TRAY 3607002 OC-C2 IMPLANT
• 00643169839359: TRAY 3607001 OC-C2 INSTRUMENT
• 00643169624160: OCCIPITAL 3600211 PRE CURVED CCM 3.5X200
• 00643169624153: OCCIPITAL 3600201 PRE CURVED TI 3.5X200
• 00643169624146: ROD 3605240 STANDARD 3.5MM X 240MM
• 00643169624139: ROD 3605120 STANDARD 3.5MM X 120MM
• 00643169624122: ROD 3602240 STANDARD 3.2MM X 240MM
• 00643169624115: ROD 3602120 STANDARD 3.2MM X 120MM
• 00643169624108: ROD 3603780 PRE-CUT 3.5MM X 80MM
• 00643169624092: ROD 3603770 PRE-CUT 3.5MM X 70MM
• 00643169624085: ROD 3603760 PRE-CUT 3.5MM X 60MM
• 00643169624078: ROD 3603750 PRE-CUT 3.5MM X 50MM
• 00643169624061: ROD 3603740 PRE-CUT 3.5MM X 40MM
• 00643169624054: ROD 3603730 PRE-CUT 3.5MM X 30MM
• 00643169624047: ROD 3603725 PRE-CUT 3.5MM X 25MM
• 00643169624030: ROD 3603807 TAPERED 3.5/5.5 X 420MM CCM
• 00643169624023: ROD 3603806 TAPERED 3.5/4.75 X 420MM CCM
• 00643169624016: ROD 3603707 TAPERED 3.5/5.5MM X 420MM
• 00643169624009: ROD 3603706 TAPERED 3.5/4.75MM X 420MM
• 00643169556614: SCREW G360T0514 OC TAPERED 5.0 X 14MM
• 00643169556607: SCREW G360T0512 OC TAPERED 5.0 X 12MM