PEEK PREVAIL™ Cervical Interbody Device

GUDID 00613994853264

HANDLE 1204477 SCREW GUIDE

MEDTRONIC SOFAMOR DANEK, INC.

Surgical drill guide, reusable

• Primary Device ID: 00613994853264
• NIH Device Record Key: 016349db-ca7d-4dea-a5d3-da912d9f4b00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEEK PREVAIL™ Cervical Interbody Device
• Version Model Number: 1204477
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00613994853264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113252

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[00613994853264]

Moist Heat or Steam Sterilization

[00613994853264]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2015-09-01

On-Brand Devices [PEEK PREVAIL™ Cervical Interbody Device]

• 00613994853264: HANDLE 1204477 SCREW GUIDE
• 00613994753922: SCREW GUIDE 1225555
• 00613994646019: SPACER 9010000039 PRV PK 16X12X9
• 00613994646002: SPACER 9010000038 PRV PK 16X12X8
• 00613994645999: SPACER 9010000037 PRV PK 16X12X7
• 00613994645982: SPACER 9010000036 PRV PK 16X12X6
• 00613994645975: SPACER 9010000035 PRV PK 16X12X5
• 00613994645777: TRASP 9010000049 CERVICAL 9X16X12
• 00613994645760: TRASP 9010000048 CERVICAL 8X16X12
• 00613994645753: TRASP 9010000047 CERVICAL 7X16X12
• 00613994645746: TRASP 9010000046 CERVICAL 6X16X12
• 00613994645739: TRASP 9010000045 CERVICAL 5X16X12
• 00613994502124: IMPLANT 4210964 STANDALONE 16 X 14 X 9MM
• 00613994502117: IMPLANT 4210864 STANDALONE 16 X 14 X 8MM
• 00613994502100: IMPLANT 4210764 STANDALONE 16 X 14 X 7MM
• 00613994502094: IMPLANT 4210664 STANDALONE 16 X 14 X 6MM
• 00613994502087: IMPLANT 4210564 STANDALONE 16 X 14 X 5MM