PRESTIGE® LP Cervical Disc System

GUDID 00613994490384

TRIAL 6973268 IMPLANT

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00613994490384
• NIH Device Record Key: 4e94ebe7-8cbb-4fbf-ba42-70a64be28288
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRESTIGE® LP Cervical Disc System
• Version Model Number: 6973268
• 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: false
• 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

Device Dimensions

• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994490384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P090029

FDA Product Code

• MJO: PROSTHESIS, INTERVERTEBRAL DISC

Sterilization

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

[00613994490384]

Moist Heat or Steam Sterilization

[00613994490384]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2014-09-25

On-Brand Devices [PRESTIGE® LP Cervical Disc System]

• 00613994714862: INNER SHAFT 6973080 8MM INSERTER US
• 00613994714855: INNER SHAFT 6973070 7MM INSERTER US
• 00613994714848: INNER SHAFT 6973060 6MM INSERTER US
• 00613994714824: HANDLE 6973000 INSERTER HANDLE US
• 00613994493736: PRESTIGE LP DISC 6X12MM
• 00613994493705: PRESTIGE LP DISC 6X14MM
• 00613994493699: PRESTIGE LP DISC 7X14MM
• 00613994493682: DISC 6972480 PRESTIGE 8X14MM
• 00613994493668: PRESTIGE LP DISC 6X16MM
• 00613994493651: PRESTIGE LP DISC 7X16MM
• 00613994493644: DISC 6972680 PRESTIGE 8X16MM
• 00613994493637: PRESTIGE LP DISC 6X18MM
• 00613994493620: PRESTIGE LP DISC 7X18MM
• 00613994493613: DISC 6972880 PRESTIGE 8X18MM
• 00613994490728: PUNCH 6972426 RAIL
• 00613994490704: PUNCH 6972446 RAIL
• 00613994490698: PUNCH 6972447 RAIL
• 00613994490681: PUNCH 6972448 RAIL
• 00613994490667: PUNCH 6972466 RAIL
• 00613994490650: PUNCH 6972467 RAIL
• 00613994490643: PUNCH 6972468 RAIL
• 00613994490636: PUNCH 6972486 RAIL
• 00613994490629: PUNCH 6972487 RAIL
• 00613994490612: PUNCH 6972488 RAIL
• 00613994490469: TRIAL 6973226 IMPLANT
• 00613994490445: TRIAL 6973246 IMPLANT
• 00613994490438: TRIAL 6973247 IMPLANT
• 00613994490421: TRIAL 6973248 IMPLANT
• 00613994490407: TRIAL 6973266 IMPLANT
• 00613994490391: TRIAL 6973267 IMPLANT
• 00613994490384: TRIAL 6973268 IMPLANT
• 00613994490377: TRIAL 6973286 IMPLANT
• 00613994490360: TRIAL 6973287 IMPLANT
• 00613994490353: TRIAL 6973288 IMPLANT
• 00613994490339: GUIDE 6972526 CUTTER
• 00613994490315: GUIDE 6972546 CUTTER
• 00613994490308: GUIDE 6972547 CUTTER
• 00613994490292: GUIDE 6972548 CUTTER
• 00613994490278: GUIDE 6972566 CUTTER
• 00613994490261: GUIDE 6972567 CUTTER
• 00613994490254: GUIDE 6972568 CUTTER
• 00613994490247: GUIDE 6972586 CUTTER
• 00613994490230: GUIDE 6972587 CUTTER
• 00613994490223: GUIDE 6972588 CUTTER