Centerpiece Plate Fixation System

GUDID 00763000552916

TRAY 8539006 INSTRUMENT TRAY

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray, reusable

• Primary Device ID: 00763000552916
• NIH Device Record Key: 9b555753-6811-456b-8c53-c21725e091a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Centerpiece Plate Fixation System
• Version Model Number: 8539006
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00763000552916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190840

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

[00763000552916]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-27
• Device Publish Date: 2023-02-19

On-Brand Devices [Centerpiece Plate Fixation System]

• 00763000553524: RESCUE SCREW G8532469 ODLP 2.4 X 9MM
• 00763000553517: RESCUE SCREW G8532467 ODLP 2.4 X 7MM
• 00763000553500: RESCUE SCREW G8532465 ODLP 2.4 X 5MM
• 00763000553494: RESCUE SCREW G8532463 ODLP 2.4 X 3MM
• 00763000553487: BONE SCREW G8532069 ODLP 2.0 X 9MM
• 00763000553470: BONE SCREW G8532067 ODLP 2.0 X 7MM
• 00763000553463: BONE SCREW G8532065 ODLP 2.0 X 5MM
• 00763000553456: BONE SCREW G8532063 ODLP 2.0 X 3MM
• 00763000552909: LID 8539005 PLATE MODULE LID
• 00763000552893: MODULE 8539004 PLATE MODULE
• 00763000552886: LID 8539003 SCREW MODULE LID
• 00763000552879: MODULE 8539002 SCREW MODULE
• 00763000552855: TRAY 8539000 INSTRUMENT AND IMPLANT TRAY
• 00763000552251: RESCUE SCREW 8532469 ODLP 2.4 X 9MM
• 00763000552244: RESCUE SCREW 8532467 ODLP 2.4 X 7MM
• 00763000552237: RESCUE SCREW 8532465 ODLP 2.4 X 5MM
• 00763000552220: RESCUE SCREW 8532463 ODLP 2.4 X 3MM
• 00763000552213: BONE SCREW 8532069 ODLP 2.0 X 9MM
• 00763000552206: BONE SCREW 8532067 ODLP 2.0 X 7MM
• 00763000552190: BONE SCREW 8532065 ODLP 2.0 X 5MM
• 00763000552183: BONE SCREW 8532063 ODLP 2.0 X 3MM
• 00763000552916: TRAY 8539006 INSTRUMENT TRAY