CD™ SPINAL SYSTEM

GUDID 00673978053158

CONNECTOR 84154T CD HOOK ROD SCREW TI

MEDTRONIC SOFAMOR DANEK, INC.

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

• Primary Device ID: 00673978053158
• NIH Device Record Key: d24de636-a4d4-48e4-a867-b99bef08b3b9
• Commercial Distribution Discontinuation: 2018-10-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CD™ SPINAL SYSTEM
• Version Model Number: 84154T
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978053158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000476

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00673978053158]

Moist Heat or Steam Sterilization

[00673978053158]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-12
• Device Publish Date: 2015-08-24

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000918033 - Medtronic Reusable Instruments: 2024-04-16 GUIDE EX0923002 UCSS SHORT
• 00763000918040 - Medtronic Reusable Instruments: 2024-04-16 SCREWDRIVER EX0923003 UCSS FLEX SHORT
• 00763000918057 - Medtronic Reusable Instruments: 2024-04-16 DRILL BIT EX0923004 UCSS FLEX SHORT
• 00763000916145 - MSB Reusable Instruments: 2024-04-08 SCREWDRIVER EX0223017 CERVICAL
• 00763000897024 - Medtronic Reusable Instruments: 2024-04-02 BLADE X07317090 SLIM CC R 90MM
• 00763000897031 - Medtronic Reusable Instruments: 2024-04-02 BLADE X07317091 SLIM CC L 90MM
• 00763000897048 - Medtronic Reusable Instruments: 2024-04-02 BLADE X07317092 SLIM LT 90MM
• 00763000897055 - Medtronic Reusable Instruments: 2024-04-02 BLADE X07317110 SLIM CC R 110MM