CAPSTONE PTC™ Spinal System

GUDID 00643169187245

SPACER 3993608 36MM X 8MM

MEDTRONIC SOFAMOR DANEK, INC.

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• Primary Device ID: 00643169187245
• NIH Device Record Key: 7d3a9831-fc9e-40a7-a000-b149b3aa320e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPSTONE PTC™ Spinal System
• Version Model Number: 3993608
• 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
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169187245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133205

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-02

On-Brand Devices [CAPSTONE PTC™ Spinal System]

• 00643169187573: SPACER 3992206 22MM X 6MM
• 00643169187566: SPACER 3992207 22MM X 7MM
• 00643169187559: SPACER 3992208 22MM X 8MM
• 00643169187542: SPACER 3992209 22MM X 9MM
• 00643169187535: SPACER 3992210 22MM X 10MM
• 00643169187528: SPACER 3992211 22MM X 11MM
• 00643169187511: SPACER 3992212 22MM X 12MM
• 00643169187504: SPACER 3992213 22MM X 13MM
• 00643169187498: SPACER 3992214 22MM X 14MM
• 00643169187481: SPACER 3992215 22MM X 15MM
• 00643169187474: SPACER 3992216 22MM X 16MM
• 00643169187467: SPACER 3992606 26MM X 6MM
• 00643169187450: SPACER 3992607 26MM X 7MM
• 00643169187443: SPACER 3992608 26MM X 8MM
• 00643169187436: SPACER 3992609 26MM X 9MM
• 00643169187429: SPACER 3992610 26MM X 10MM
• 00643169187412: SPACER 3992611 26MM X 11MM
• 00643169187405: SPACER 3992612 26MM X 12MM
• 00643169187399: SPACER 3992613 26MM X 13MM
• 00643169187382: SPACER 3992614 26MM X 14MM
• 00643169187375: SPACER 3992615 26MM X 15MM
• 00643169187368: SPACER 3992616 26MM X 16MM
• 00643169187351: SPACER 3993207 32MM X 7MM
• 00643169187344: SPACER 3993208 32MM X 8MM
• 00643169187337: SPACER 3993209 32MM X 9MM
• 00643169187320: SPACER 3993210 32MM X 10MM
• 00643169187313: SPACER 3993211 32MM X 11MM
• 00643169187306: SPACER 3993212 32MM X 12MM
• 00643169187290: SPACER 3993213 32MM X 13MM
• 00643169187283: SPACER 3993214 32MM X 14MM
• 00643169187276: SPACER 3993215 32MM X 15MM
• 00643169187269: SPACER 3993216 32MM X 16MM
• 00643169187252: SPACER 3993607 36MM X 7MM
• 00643169187245: SPACER 3993608 36MM X 8MM
• 00643169187238: SPACER 3993609 36MM X 9MM
• 00643169187221: SPACER 3993610 36MM X 10MM
• 00643169187214: SPACER 3993611 36MM X 11MM
• 00643169187207: SPACER 3993612 36MM X 12MM
• 00643169187191: SPACER 3993613 36MM X 13MM
• 00643169187184: SPACER 3993614 36MM X 14MM
• 00643169187177: SPACER 3993615 36MM X 15MM
• 00643169187160: SPACER 3993616 36MM X 16MM