ZEPHIR® Anterior Cervical System

GUDID 00613994264855

PLATE X0706242 ZEP-WIDE-95MM

MEDTRONIC SOFAMOR DANEK, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00613994264855
• NIH Device Record Key: fa69bd38-7df2-4510-bc7d-16da17738705
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZEPHIR® Anterior Cervical System
• Version Model Number: X0706242
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994264855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994239

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

Moist Heat or Steam Sterilization

[00613994264855]

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: 2016-04-03

On-Brand Devices [ZEPHIR® Anterior Cervical System]

• 00613994544728: SCREW X0508083 ZEP SCR SD 3.5X16
• 00613994544711: SCREW X0508082 ZEP SCR SD 4.0X16
• 00613994544704: SCREW X0508081 ZEP SCR SD 4.0X14
• 00613994265050: SCREW X0706213 ZEP-SELF DRILL-D4.5-L15MM
• 00613994265043: SCREW X0706214 ZEP-SELF DRILL-D4.5-L17MM
• 00613994265036: PLATE X0706215 ZEP-WIDE-25MM
• 00613994265029: PLATE X0706216 ZEP-WIDE-27.5MM
• 00613994265012: PLATE X0706217 ZEP-WIDE-30MM
• 00613994265005: PLATE X0706218 ZEP-WIDE-32.5MM
• 00613994264992: PLATE X0706219 ZEP-WIDE-35MM
• 00613994264985: PLATE X0706220 ZEP-WIDE-37.5MM
• 00613994264978: PLATE X0706221 ZEP-WIDE-40MM
• 00613994264961: PLATE X0706222 ZEP-WIDE-42.5MM
• 00613994264954: SCREW X0706212 ZEP-SELF DRILL-D4.5-L13MM
• 00613994264947: SCREW X0706211 ZEP-SELF DRILL-D4.0-L18MM
• 00613994264930: SCREW X0706210 ZEP-SELF DRILL-D4.0-L17MM
• 00613994264923: SCREW X0706209 ZEP-SELF DRILL-D4.0-L16MM
• 00613994264916: SCREW X0706208 ZEP-SELF DRILL-D4.0-L15MM
• 00613994264909: SCREW X0706207 ZEP-SELF DRILL-D4.0-L14MM
• 00613994264893: SCREW X0706206 ZEP-SELF DRILL-D4.0-L13MM
• 00613994264886: SCREW X0706205 ZEP-SELF DRILL-D4.0-L12MM
• 00613994264879: SCREW X0706204 ZEP-SELF DRILL-D4.0-L11MM
• 00613994264862: SCREW X0706203 ZEP-SELF DRILL-D4.0-L10MM
• 00613994264855: PLATE X0706242 ZEP-WIDE-95MM
• 00613994264848: PLATE X0706241 ZEP-WIDE-90MM
• 00613994264831: PLATE X0706240 ZEP-WIDE-87.5MM
• 00613994264824: PLATE X0706239 ZEP-WIDE-85MM
• 00613994264817: PLATE X0706238 ZEP-WIDE-82.5MM
• 00613994264800: PLATE X0706237 ZEP-WIDE-80MM
• 00613994264794: PLATE X0706236 ZEP-WIDE-77.5MM
• 00613994264787: PLATE X0706235 ZEP-WIDE-75MM
• 00613994264770: PLATE X0706234 ZEP-WIDE-72.5MM
• 00613994264763: PLATE X0706233 ZEP-WIDE-70MM
• 00613994264756: PLATE X0706232 ZEP-WIDE-67.5MM
• 00613994264749: PLATE X0706231 ZEP-WIDE-65MM
• 00613994264732: PLATE X0706230 ZEP-WIDE-62.5MM
• 00613994264725: PLATE X0706229 ZEP-WIDE-60MM
• 00613994264718: PLATE X0706228 ZEP-WIDE-57.5MM
• 00613994264701: PLATE X0706227 ZEP-WIDE-55MM
• 00613994264695: PLATE X0706226 ZEP-WIDE-52.5MM
• 00613994264688: PLATE X0706225 ZEP-WIDE-50MM
• 00613994264671: PLATE X0706224 ZEP-WIDE-47.5MM
• 00613994264664: PLATE X0706223 ZEP-WIDE-45MM
• 00681490540957: SCREW 8792717 VASD CNCLLS 4.0X17MM
• 00681490540940: SCREW 8792715 VAST CNCLLS 4.0X15MM
• 00681490540933: SCREW 8792713 VAST CNCLLS 4.0X13MM
• 00681490540926: PLATE 8799170 ZEPHIR 70MM TI
• 00681490540919: PLATE 8799167 ZEPHIR 67.5MM TI
• 00681490540902: PLATE 8799165 ZEPHIR 65MM TI
• 00681490540896: PLATE 8799162 ZEPHIR 62.5MM TI