PREMIER(TM) Anterior Cervical Plate System

GUDID 00721902710469

PLATE 6861137 37.5MM ANTERIOR CERVICAL

MEDTRONIC SOFAMOR DANEK, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00721902710469
• NIH Device Record Key: 038fd6c0-a22f-4b17-b7f9-c4a05d4fd4c7
• Commercial Distribution Discontinuation: 2018-10-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PREMIER(TM) Anterior Cervical Plate System
• Version Model Number: 6861137
• 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

Device Dimensions

• Width: 37.5 Millimeter
• Width: 37.5 Millimeter
• Width: 37.5 Millimeter
• Width: 37.5 Millimeter
• Width: 37.5 Millimeter
• Width: 37.5 Millimeter
• Width: 37.5 Millimeter
• Width: 37.5 Millimeter
• Width: 37.5 Millimeter
• Width: 37.5 Millimeter
• Width: 37.5 Millimeter
• Width: 37.5 Millimeter
• Width: 37.5 Millimeter
• Width: 37.5 Millimeter
• Width: 37.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902710469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021761

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

[00721902710469]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-30
• Device Publish Date: 2015-08-18

On-Brand Devices [PREMIER(TM) Anterior Cervical Plate System]

• 00721902710513: PLATE 6861182 82.5MM ANTERIOR CERVICAL
• 00721902710469: PLATE 6861137 37.5MM ANTERIOR CERVICAL
• 00721902688362: PLATE 6861200 100MM ANTERIOR CERVICAL
• 00721902688348: PLATE 6861185 85MM ANTERIOR CERVICAL
• 00721902688294: PLATE 6861130 30MM ANTERIOR CERVICAL
• 00721902615818: 50MM MODIFIED PREMIER PLATE
• 00721902615801: 47.5MM MODIFIED PREMIER PLATE
• 00721902615795: 45MM MODIFIED PREMIER PLATE
• 00721902615788: 42.5MM MODIFIED PREMIER PLATE
• 00721902615771: 40MM MODIFIED PREMIER PLATE
• 00721902615764: 37.5MM MODIFIED PREMIER PLATE
• 00721902615757: 35MM MODIFIED PREMIER PLATE
• 00721902615740: 32.5MM MODIFIED PREMIER PLATE
• 00721902615733: 30MM MODIFIED PREMIER PLATE
• 00721902615726: 27.5MM MODIFIED PREMIER PLATE
• 00721902615719: 25MM MODIFIED PREMIER PLATE
• 00721902615443: 23MM MODIFIED PREMIER PLATE
• 00721902500459: PLATE 6861177 77.5 MM ANT CERV
• 00721902500435: PLATE 6861175 75 MM ANT CERV
• 00721902500398: PLATE 6861167 67.5 MM ANT CERV
• 00721902500381: PLATE 6861165 65 MM ANT CERV
• 00721902500336: PLATE 6861157 57.5 MM ANT CERV
• 00721902500329: PLATE 6861150 50 MM ANT CERV PLATE