MSB/None

GUDID 00673978950426

SCREW 8437050 DYLC BOLT 7.0X50 TI

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00673978950426
• NIH Device Record Key: 878c45ba-6ff0-4b99-bba1-47d8d5811d12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MSB/None
• Version Model Number: 8437050
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978950426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001532

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

Moist Heat or Steam Sterilization

[00673978950426]

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: 2015-08-19

On-Brand Devices [MSB/None]

• 00673978950525: SCREW 8437550 DYLC BOLT 7.5X50 TI
• 00673978950518: SCREW 8437545 DYLC BOLT 7.5X45 TI
• 00673978950501: SCREW 8437540 DYLC BOLT 7.5X40 TI
• 00673978950426: SCREW 8437050 DYLC BOLT 7.0X50 TI
• 00673978950419: SCREW 8437045 DYLC BOLT 7.0X45 TI
• 00673978950402: SCREW 8437040 DYLC BOLT 7.0X40 TI
• 00673978950396: SCREW 8437035 DYLC BOLT 7.0X35 TI
• 00673978950372: SCREW 8436550 DYLC BOLT 6.5X50 TI
• 00673978950365: SCREW 8436545 DYLC BOLT 6.5X45 TI
• 00673978950358: SCREW 8436540 DYLC BOLT 6.5X40 TI
• 00673978950341: SCREW 8436535 DYLC BOLT 6.5X35 TI
• 00673978950303: SCREW 8435545 DYLC BOLT 5.5X45 TI
• 00673978950297: SCREW 8435540 DYLC BOLT 5.5X40 TI
• 00673978950259: SCREW 8435005 DY CLASSIC WASHER NUTTI
• 00673978159713: UNIT ROD 6.35X27CM SS
• 00673978159706: UNIT ROD 6.35X29CM SS
• 00673978109701: SCREW C374L70 CDH SAC BLK 7.0X70
• 00673978109664: SCREW C374L60 CDH SAC BLK 7.0X60
• 00673978109626: SCREW C374L50 CDH SAC BLK 7.0X50
• 00673978109589: SCREW C374L40 CDH SAC BLK 7.0X40
• 00673978109565: SCREW C374L35 CDH SAC BLK 7.0X35