CORNERSTONE® PSR Cervical Fusion System

GUDID 00613994366009

IMPLANT 6284511 PEEK CRV 11X11X 5MM

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00613994366009
• NIH Device Record Key: bc2c2127-583b-4f06-81ce-c88bd14c6159
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORNERSTONE® PSR Cervical Fusion System
• Version Model Number: 6284511
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Depth: 11 Millimeter
• Depth: 11 Millimeter
• Depth: 11 Millimeter
• Depth: 11 Millimeter
• Depth: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter
• Height: 5 Millimeter
• Width: 11 Millimeter
• Depth: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994366009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100214

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

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: 2015-07-08

On-Brand Devices [CORNERSTONE® PSR Cervical Fusion System]

• 00613994367495: IMPLANT 6284544 PEEK CRV 14X14X 5MM
• 00613994367488: IMPLANT 6284644 PEEK CRV 14X14X 6MM
• 00613994367471: IMPLANT 6284744 PEEK CRV 14X14X 7MM
• 00613994367464: IMPLANT 6284844 PEEK CRV 14X14X 8MM
• 00613994367457: IMPLANT 6284944 PEEK CRV 14X14X 9MM
• 00613994367440: IMPLANT 6284044 PEEK CRV 14X14X 10MM
• 00613994367433: IMPLANT 6284144 PEEK CRV 14X14X 11MM
• 00613994367426: IMPLANT 6284244 PEEK CRV 14X14X 12MM
• 00613994367419: IMPLANT 6284344 PEEK CRV 14X14X 13MM
• 00613994366108: IMPLANT 6284541 PEEK CRV 14X11X5MM
• 00613994366092: IMPLANT 6284641 PEEK CRV 14X11X6MM
• 00613994366085: IMPLANT 6284741 PEEK CRV 14X11X7MM
• 00613994366078: IMPLANT 6284841 PEEK CRV 14X11X8MM
• 00613994366061: IMPLANT 6284941 PEEK CRV 14X11X9MM
• 00613994366054: IMPLANT 6284041 PEEK CRV 14X11X10MM
• 00613994366047: IMPLANT 6284141 PEEK CRV 14X11X11MM
• 00613994366030: IMPLANT 6284241 PEEK CRV 14X11X12MM
• 00613994366023: IMPLANT 6284341 PEEK CRV 14X11X13MM
• 00613994366009: IMPLANT 6284511 PEEK CRV 11X11X 5MM
• 00613994365996: IMPLANT 6284611 PEEK CRV 11X11X 6MM
• 00613994365989: IMPLANT 6284711 PEEK CRV 11X11X 7MM
• 00613994365972: IMPLANT 6284811 PEEK CRV 11X11X 8MM
• 00613994365965: IMPLANT 6284911 PEEK CRV 11X11X 9MM
• 00613994365958: IMPLANT 6284011 PEEK CRV 11X11X 10MM
• 00613994365941: IMPLANT 6284111 PEEK CRV 11X11X 11MM
• 00613994365934: IMPLANT 6284211 PEEK CRV 11X11X 12MM
• 00613994365927: IMPLANT 6284311 PEEK CRV 11X11X 13MM
• 00613994158130: INSTRUMENT 6273844 DUAL TRL 14X14 4 DGRE
• 00613994158123: INSTRUMENT 6273841 DUAL TRL 14X11 4 DGRE
• 00613994158116: INSTRUMENT 6273811 DUAL TRL 11X11 4 DGRE
• 00613994158093: INSTRUMENT 6273644 DUAL TRL 14X14 4 DGRE
• 00613994158086: INSTRUMENT 6273641 DUAL TRL 14X11 4 DGRE
• 00613994158079: INSTRUMENT 6273611 DUAL TRL 11X11 4 DGRE
• 00613994158055: INSTRUMENT 6273544 DUAL TRL 14X14 4 DGRE
• 00613994158048: INSTRUMENT 6273541 DUAL TRL 14X11 4 DGRE
• 00613994158031: INSTRUMENT 6273511 DUAL TRL 11X11 4 DGRE
• 00613994157980: INSTRUMENT 6273244 DUAL TRL 14X14 4 DGRE
• 00613994157966: INSTRUMENT 6273241 DUAL TRL 14X11 4 DGRE
• 00613994157959: INSTRUMENT 6273211 DUAL TRL 11X11 4 DGRE
• 00613994157942: INSTRUMENT 6273144 DUAL TRL 14X14 4 DGRE
• 00613994157928: INSTRUMENT 6273141 DUAL TRL 14X11 4 DGRE
• 00613994157881: INSTRUMENT 6273111 DUAL TRL 11X11 4 DGRE
• 00613994116598: INSTRUMENT 6274944 PSR TRASP 9X14X14
• 00613994116581: INSTRUMENT 6274941 PSR TRASP 9X14X11
• 00613994116574: INSTRUMENT 6274911 PSR TRASP 9X11X11
• 00613994116567: INSTRUMENT 6274844 PSR TRASP 8X14X14
• 00613994116550: INSTRUMENT 6274841 PSR TRASP 8X14X11
• 00613994116543: INSTRUMENT 6274811 PSR TRASP 8X11X11
• 00613994116536: INSTRUMENT 6274744 PSR TRASP 7X14X14
• 00613994116529: INSTRUMENT 6274741 PSR TRASP 7X14X11