CENTERPIECE™ Plate Fixation System

GUDID 00885074317472

PLATE 853012WM OD WIDE MOUTH 12MM

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00885074317472
• NIH Device Record Key: 21a60163-7300-477e-bfda-c1bfc8c697b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CENTERPIECE™ Plate Fixation System
• Version Model Number: 853012WM
• 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

• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074317472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050082

FDA Product Code

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

Sterilization

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

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

Moist Heat or Steam Sterilization

[00885074317472]

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 [CENTERPIECE™ Plate Fixation System]

• 00613994866158: SCREW X0810582 CEN TI DEEP DRIVE 3.0X11
• 00613994866141: SCREW X0810581 CEN TI DEEP DRIVE 3.0X9
• 00613994866134: SCREW X0810580 CEN TI DEEP DRIVE 3.0X7
• 00613994866127: SCREW X0810579 CEN TI DEEP DRIVE 3.0X5
• 00613994866110: SCREW X0810578 CEN TI DEEP DRIVE 2.6X11
• 00613994866103: SCREW X0810577 CEN TI DEEP DRIVE 2.6X9
• 00613994866097: SCREW X0810576 CEN TI DEEP DRIVE 2.6X7
• 00613994866080: SCREW X0810575 CEN TI DEEP DRIVE 2.6X5
• 00613994270825: Screw X1006038 3.0 x 4mm
• 00613994270818: Screw X1006037 2.6 x 4mm
• 00721902799105: CASE 176-859R LP SCREW CADDY
• 00721902742835: BONE SCREW 853-511 3.0 X 11MM
• 00721902742828: BONE SCREW 853-509 3.0 X 9MM
• 00721902742811: BONE SCREW 853-507 3.0 X 7MM
• 00721902742804: BONE SCREW 853-505 3.0 X 5MM
• 00721902742781: BONE SCREW 853-471 2.6 X 11MM
• 00721902742774: BONE SCREW 853-469 2.6 X 9MM
• 00721902742750: BONE SCREW 853-467 2.6 X 7MM
• 00721902742743: BONE SCREW 853-465 2.6 X 5MM
• 00721902569227: PLATE 853-410 10MM GRFT PLT
• 00721902569203: TRAUMA 853-010 10MM OD PLATE
• 00721902427381: 18MM GRAFT PLATE
• 00721902427374: PLATE 853-416 16MM GRFT PLT
• 00721902427367: PLATE 853-414 14MM GRFT PLT
• 00721902427350: PLATE 853-412 12MM GRFT PLT
• 00721902427312: PLATE 853-018 18MM OD
• 00721902427305: TRAUMA 853-016 16MM OD PLATE
• 00721902427299: TRAUMA 853-014 14MM OD PLATE
• 00721902427282: TRAUMA 853-012 12MM OD PLATE
• 00885074527765: 8MM GRAFT PLATE
• 00885074527758: OD LAT WIDE MOUTH PLATE 18MM
• 00885074527741: OD LAT WIDE MOUTH PLATE 16MM
• 00885074527734: PLATE 853014LW OD LAT WIDE MOUTH 14MM
• 00885074527727: PLATE 853012LW OD LAT WIDE MOUTH 12MM
• 00885074527710: PLATE 853010LW OD LAT WIDE MOUTH 10MM
• 00885074527703: OD LAT WIDE MOUTH PLATE 8MM
• 00885074527598: 8MM OD PLATE
• 00885074527543: PLATE 8530000 TROUGH PLATE
• 00885074317632: GP LATERAL HOLE PLATE 16MM
• 00885074317625: PLATE 853414LH GP LATERAL HOLE 14MM
• 00885074317601: PLATE 853412LH GP LATERAL 12MM
• 00885074317595: PLATE 853410LH GP LATERAL HOLE 10MM
• 00885074317571: GP LATERAL HOLE PLATE 8MM
• 00885074317564: OD WIDE MOUTH PLATE 18MM
• 00885074317540: OD LATERAL HOLE PLATE 18MM
• 00885074317533: OD WIDE MOUTH PLATE 16MM
• 00885074317519: OD LATERAL HOLE PLATE 16MM
• 00885074317502: PLATE 853014WM OD WIDE MOUTH 14MM
• 00885074317489: PLATE 853014LH OD LATERAL HOLE 14MM
• 00885074317472: PLATE 853012WM OD WIDE MOUTH 12MM