PRESTIGE® Cervical Disc System

GUDID 00613994129222

DISC 6961660 CERVICAL DISC 6MM X 16MM

MEDTRONIC SOFAMOR DANEK, INC.

Cervical total disc replacement prosthesis, sterile

• Primary Device ID: 00613994129222
• NIH Device Record Key: 66043b3c-36b8-4d37-b785-e1f772bb4c7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRESTIGE® Cervical Disc System
• Version Model Number: 6961660
• 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
• 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

• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter
• Depth: 16 Millimeter
• Height: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994129222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P060018

FDA Product Code

• MJO: PROSTHESIS, INTERVERTEBRAL DISC

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: 2014-09-23

On-Brand Devices [PRESTIGE® Cervical Disc System]

• 00613994237064: TRIAL 6972226 IMPLANT TRIAL 6X12
• 00613994237040: TRIAL 6972246 IMPLANT TRIAL 6X14
• 00613994237033: TRIAL 6972247 IMPLANT TRIAL 7X14
• 00613994237019: TRIAL 6972266 IMPLANT TRIAL 6X16
• 00613994237002: TRIAL 6972267 IMPLANT TRIAL 7X16
• 00613994236982: TRIAL 6972287 IMPLANT TRIAL 7X18
• 00613994129253: DISC 6961870 CERVICAL DISC 7MM X 18MM
• 00613994129239: DISC 6961670 CERVICAL DISC 7MM X 16MM
• 00613994129222: DISC 6961660 CERVICAL DISC 6MM X 16MM
• 00613994129215: DISC 6961460 CERVICAL DISC 6MM X 14MM
• 00721902723254: DISC 6961470 PRESTIGE ARTIFICIAL 7X14MM
• 00721902723223: PRESTIGE ARTIFICIAL DISC 6X12MM
• 00721902451959: SCREW 6960120 LOCK
• 00721902440250: SCREW 6960113 PRSTG BONE FAST 4.5X13MM
• 00721902440243: SCREW 6960015 PRSTG BONE FAST 4.0X15MM
• 00721902440236: SCREW 6960013 PRSTG BON FAST 4.0X13MM