PREMIER® Anterior Cervical Plate System

GUDID 00721902568251

MODIFIED PLATE, 67.5MM

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00721902568251
• NIH Device Record Key: c9824f81-4c8f-4d06-bdbd-2b5d5144a2b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREMIER® Anterior Cervical Plate System
• Version Model Number: X0802167
• 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: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter
• Width: 67.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902568251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992110

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

Moist Heat or Steam Sterilization

[00721902568251]

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: 2015-08-18

On-Brand Devices [PREMIER® Anterior Cervical Plate System]

• 00613994557568: PLATE X1108058 PRE PLT 32.5MM 2LEV
• 00613994234889: PLATE X0206145 PRE FSP PLT 23MM 1LEV
• 00613994234872: PLATE X0206147 PRE FSP PLT 27.5MM 1LEV
• 00613994234865: PLATE X0206148 PRE FSP PLT 37.5MM 2LEV
• 00613994234858: PLATE X0206149 PRE FSP PLT 40MM 2LEV
• 00613994234841: PLATE X0206150 PRE FSP PLT 42.5MM 2LEV
• 00613994234834: PLATE X0206151 PRE FSP PLT 45MM 2LEV
• 00681490519304: CASE 1860503 PREMIER SCREW TRAY MODULE
• 00681490519281: CASE 1860501 GENERIC BASE PREMIER
• 00681490482462: PLATE 6860210 110 MM ANT CERV
• 00681490482455: PLATE 6860205 105 MM ANT CERV
• 00681490482448: PLATE 6860200 100 MM ANT CERV
• 00681490482431: PLATE 6860195 95 MM ANT CERV
• 00681490482424: PLATE 6860190 90 MM ANT CERV
• 00681490482417: PLATE 6860187 87 5MM ANT CERV
• 00681490482400: PLATE 6860185 85 MM ANT CERV
• 00681490482394: PLATE 6860182 82 5MM ANT CERV
• 00681490482387: PLATE 6860180 80 MM ANT CERV
• 00681490482370: PLATE 6860177 77 5MM ANT CERV
• 00681490482363: PLATE 6860175 75 MM ANT CERV
• 00681490482356: PLATE 6860172 72.5MM ANTERIOR CERVICAL
• 00681490482349: PLATE 6860170 70 MM ANTERIOR CERVICAL
• 00681490482332: PLATE 6860167 67.5MM ANTERIOR CERVICAL
• 00681490482325: PLATE 6860165 65 MM ANTERIOR CERVICAL
• 00681490482318: PLATE 6860162 62.5MM ANTERIOR CERVICAL
• 00681490482301: PLATE 6860160 60 MM ANTERIOR CERVICAL
• 00681490482295: PLATE 6860157 57.5MM ANTERIOR CERVICAL
• 00681490482288: PLATE 6860155 55 MM ANTERIOR CERVICAL
• 00681490482271: PLATE 6860152 52.5MM ANTERIOR CERVICAL
• 00681490482264: PLATE 6860150 50 MM ANTERIOR CERVICAL
• 00681490482257: PLATE 6860147 47.5MM ANTERIOR CERVICAL
• 00681490482240: PLATE 6860145 45 MM ANTERIOR CERVICAL
• 00681490482233: PLATE 6860142 42.5MM ANTERIOR CERVICAL
• 00681490482226: PLATE 6860140 40 MM ANTERIOR CERVICAL
• 00681490482219: PLATE 6860137 37.5MM ANTERIOR CERVICAL
• 00681490482202: PLATE 6860135 35 MM ANTERIOR CERVICAL
• 00681490482196: PLATE 6860132 32.5MM ANTERIOR CERVICAL
• 00681490482189: PLATE 6860130 30 MM ANTERIOR CERVICAL
• 00681490482172: PLATE 6860127 27.5MM ANTERIOR CERVICAL
• 00681490482165: PLATE 6860125 25 MM ANTERIOR CERVICAL
• 00681490482158: PLATE 6860123 23 MM ANTERIOR CERVICAL
• 00681490482141: BONE SCREW 6860057 SELF TAPPING 4.5X17MM
• 00681490482134: BONE SCREW 6860055 SELF TAPPING 4.5X15MM
• 00681490482127: SCREW 6860053 VA SELF TAPPING 4.5X13MM
• 00681490482110: SCREW 6860020 VA SELF TAPPING 4.0X20MM
• 00681490482103: SCREW 6860019 VA SELF TAPPING 4.0X19MM
• 00681490482097: SCREW 6860018 VA SELF TAPPING 4.0X18MM
• 00681490482080: SCREW 6860017 VA SELF TAPPING 4.0X17MM
• 00681490482073: SCREW 6860016 VAST CNCLLS 4.0X16MM
• 00681490482066: SCREW 6860015 VAST CNCLLS 4.0X15MM