Centerpiece Plate Fixation System

GUDID 00763000552237

RESCUE SCREW 8532465 ODLP 2.4 X 5MM

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 Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile 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: 00763000552237
• NIH Device Record Key: 0133d284-7ea6-4e47-9766-4129d801e1d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Centerpiece Plate Fixation System
• Version Model Number: 8532465
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000552237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212428

FDA Product Code

• NQW: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-18
• Device Publish Date: 2022-01-10

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