PERIMETER® C Spinal System

GUDID 00613994351166

SPACER 6360832 PERIMETER C 8X13X12

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00613994351166
• NIH Device Record Key: abba0acd-a01f-4a7e-8e19-06a81d0b8757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERIMETER® C Spinal System
• Version Model Number: 6360832
• 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: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994351166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100967

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-02

On-Brand Devices [PERIMETER® C Spinal System]

• 00613994351289: SPACER 6360032 PERIMETER C 10X13X12
• 00613994351272: SPACER 6360053 PERIMETER C 10X15X13
• 00613994351265: SPACER 6360132 PERIMETER C 11X13X12
• 00613994351258: SPACER 6360153 PERIMETER C 11X15X13
• 00613994351241: SPACER 6360232 PERIMETER C 12X13X12
• 00613994351234: SPACER 6360253 PERIMETER C 12X15X13
• 00613994351227: SPACER 6360532 PERIMETER C 5X13X12
• 00613994351210: SPACER 6360553 PERIMETER C 5X15X13
• 00613994351203: SPACER 6360632 PERIMETER C 6X13X12
• 00613994351197: SPACER 6360653 PERIMETER C 6X15X13
• 00613994351180: SPACER 6360732 PERIMETER C 7X13X12
• 00613994351173: SPACER 6360753 PERIMETER C 7X15X13
• 00613994351166: SPACER 6360832 PERIMETER C 8X13X12
• 00613994351159: SPACER 6360853 PERIMETER C 8X15X13
• 00613994351142: SPACER 6360932 PERIMETER C 9X13X12
• 00613994351135: SPACER 6360953 PERIMETER C 9X15X13
• 00643169584389: SPACR X1214546 PER C TI STER 6D 12X15X13
• 00643169584372: SPACR X1214545 PER C TI STER 6D 11X15X13
• 00643169584365: SPACR X1214544 PER C TI STER 6D 10X15X13
• 00643169584358: SPACR X1214543 PER C TI STER 6D 9X15X13
• 00643169584341: SPACR X1214542 PER C TI STER 6D 8X15X13
• 00643169584334: SPACR X1214541 PER C TI STER 6D 7X15X13
• 00643169584327: SPACR X1214540 PER C TI STER 6D 6X15X13
• 00643169584310: SPACR X1214539 PER C TI STER 6D 5X15X13
• 00643169584303: SPACR X1214538 PER C TI STER 6D 12X13X12
• 00643169584297: SPACR X1214537 PER C TI STER 6D 11X13X12
• 00643169584280: SPACR X1214536 PER C TI STER 6D 10X13X12
• 00643169584273: SPACR X1214535 PER C TI STER 6D 9X13X12
• 00643169584266: SPACR X1214534 PER C TI STER 6D 8X13X12
• 00643169584259: SPACR X1214533 PER C TI STER 6D 7X13X12
• 00643169584242: SPACR X1214532 PER C TI STER 6D 6X13X12
• 00643169584235: SPACR X1214531 PER C TI STER 6D 5X13X12
• 00643169200746: SPACER X0312085 TI PER C XS 12X15X13
• 00643169200739: SPACER X0312084 TI PER C XS 11X15X13
• 00643169200722: SPACER X0312083 TI PER C XS 10X15X13
• 00643169200715: SPACER X0312082 TI PER C XS 9X15X13
• 00643169200708: SPACER X0312081 TI PER C XS 8X15X13
• 00643169200692: SPACER X0312080 TI PER C XS 7X15X13
• 00643169200685: SPACER X0312079 TI PER C XS 6X15X13
• 00643169200678: SPACER X0312078 TI PER C XS 5X15X13
• 00643169200661: SPACER X0312077 TI PER C XS 12X13X12
• 00643169200654: SPACER X0312076 TI PER C XS 11X13X12
• 00643169200647: SPACER X0312075 TI PER C XS 10X13X12
• 00643169200630: SPACER X0312074 TI PER C XS 9X13X12
• 00643169200623: SPACER X0312073 TI PER C XS 8X13X12
• 00643169200616: SPACER X0312072 TI PER C XS 7X13X12
• 00643169200609: SPACER X0312071 TI PER C XS 6X13X12
• 00643169200593: SPACER X0312070 TI PER C XS 5X13X12