PRESTIGE LP™

GUDID 00613994493712

DISC 6972450 PRESTIGE

MEDTRONIC SOFAMOR DANEK, INC.

Cervical total disc replacement prosthesis, sterile Cervical total disc replacement prosthesis, sterile Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular

• Primary Device ID: 00613994493712
• NIH Device Record Key: a4e047d9-8e9b-4d43-93aa-97888d61a7f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRESTIGE LP™
• Version Model Number: 6972450
• 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: true
• 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

Device Dimensions

• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter
• Depth: 14 Millimeter
• Height: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994493712 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P090029

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: 2016-08-28

On-Brand Devices [PRESTIGE LP™]

• 00613994714831: INNER SHAFT 6973050 5MM INSERTER US
• 00613994493743: DISC 6972250 PRESTIGE
• 00613994493712: DISC 6972450 PRESTIGE
• 00613994493675: DISC 6972650 PRESTIGE
• 00613994490735: PUNCH 6972425 RAIL
• 00613994490711: PUNCH 6972445 RAIL
• 00613994490476: TRIAL 6973225 IMPLANT
• 00613994490452: TRIAL 6973245 IMPLANT
• 00613994490414: TRIAL 6973265 IMPLANT
• 00613994490346: GUIDE 6972525 CUTTER
• 00613994490322: GUIDE 6972545 CUTTER