VENTURE™ Anterior Cervical Plate System

GUDID 00613994143372

PLATE X1205102 VEN SCR ST VA 4.0X20

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00613994143372
• NIH Device Record Key: 3b96343f-a91f-418d-8aca-92a5503afaf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTURE™ Anterior Cervical Plate System
• Version Model Number: X1205102
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994143372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042922

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00613994143372]

Moist Heat or Steam Sterilization

[00613994143372]

Moist Heat or Steam Sterilization

[00613994143372]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-07

On-Brand Devices [VENTURE™ Anterior Cervical Plate System]

• 00613994143372: PLATE X1205102 VEN SCR ST VA 4.0X20
• 00613994143365: PLATE X1205101 VEN SCR ST VA 4.0X18
• 00613994143358: PLATE X1205100 VEN SCR ST VA 4.0X16
• 00613994143341: PLATE X1205099 VEN SCR ST VA 4.0X14
• 00613994143310: PLATE X1205096 VEN SCR ST FA 4.0X20
• 00613994143303: PLATE X1205095 VEN SCR ST FA 4.0X18
• 00613994143297: PLATE X1205094 VEN SCR ST FA 4.0X16
• 00613994143280: PLATE X1205093 VEN SCR ST FA 4.0X14
• 00613994143273: PLATE X1205092 VEN SCR ST FA 4.0X12