PERIMETER® Interbody Fusion Device

GUDID 00613994916235

SPACER X0910119 PER TI LG 12D 30X20

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00613994916235
• NIH Device Record Key: 1e229b07-1bc0-480a-9390-fa1fbff3fe9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERIMETER® Interbody Fusion Device
• Version Model Number: X0910119
• 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

Device Dimensions

• Length: 24 Millimeter
• Length: 24 Millimeter
• Length: 24 Millimeter
• Length: 24 Millimeter
• Length: 24 Millimeter
• Length: 24 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994916235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111525

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00613994916235]

Moist Heat or Steam Sterilization

[00613994916235]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-06-29

On-Brand Devices [PERIMETER® Interbody Fusion Device]

• 00613994916341: SPACER X0910108 PER TI LG 8D 30X12
• 00613994916334: SPACER X0910109 PER TI LG 8D 30X14
• 00613994916327: SPACER X0910110 PER TI LG 8D 30X16
• 00613994916310: SPACER X0910111 PER TI LG 8D 30X18
• 00613994916303: SPACER X0910112 PER TI LG 8D 30X20
• 00613994916297: SPACER X0910113 PER TI LG 12D 30X8
• 00613994916280: SPACER X0910114 PER TI LG 12D 30X10
• 00613994916273: SPACER X0910115 PER TI LG 12D 30X12
• 00613994916266: SPACER X0910116 PER TI LG 12D 30X14
• 00613994916259: SPACER X0910117 PER TI LG 12D 30X16
• 00613994916242: SPACER X0910118 PER TI LG 12D 30X18
• 00613994916235: SPACER X0910119 PER TI LG 12D 30X20
• 00613994916228: SPACER X0910120 PER TI XL 8D 36X8
• 00613994916211: SPACER X0910121 PER TI XL 8D 36X10
• 00613994916204: SPACER X0910122 PER TI XL 8D 36X12
• 00613994916198: SPACER X0910107 PER TI LG 8D 30X10
• 00613994916181: SPACER X0910092 PER TI MD 8D 26X8
• 00613994916174: SPACER X0910093 PER TI MD 8D 26X10
• 00613994916167: SPACER X0910094 PER TI MD 8D 26X12
• 00613994916150: SPACER X0910095 PER TI MD 8D 26X14
• 00613994916143: SPACER X0910096 PER TI MD 8D 26X16
• 00613994916136: SPACER X0910097 PER TI MD 8D 26X18
• 00613994916129: SPACER X0910098 PER TI MD 8D 26X20
• 00613994916112: SPACER X0910099 PER TI MD 12D 26X8
• 00613994916105: SPACER X0910100 PER TI MD 12D 26X10
• 00613994916099: SPACER X0910101 PER TI MD 12D 26X12
• 00613994916082: SPACER X0910102 PER TI MD 12D 26X14
• 00613994916075: SPACER X0910103 PER TI MD 12D 26X16
• 00613994916068: SPACER X0910104 PER TI MD 12D 26X18
• 00613994916051: SPACER X0910105 PER TI MD 12D 26X20
• 00613994916044: SPACER X0910106 PER TI LG 8D 30X8
• 00613994916037: SPACER X1110073 PER TI XXL 8D 38X18
• 00613994916020: SPACER X1110074 PER TI XXL 8D 38X20
• 00613994916013: SPACER X1110075 PER TI XXL 12D 38X8
• 00613994916006: SPACER X1110076 PER TI XXL 12D 38X10
• 00613994915993: SPACER X1110077 PER TI XXL 12D 38X12
• 00613994915986: SPACER X1110078 PER TI XXL 12D 38X14
• 00613994915979: SPACER X1110079 PER TI XXL 12D 38X16
• 00613994915962: SPACER X1110080 PER TI XXL 12D 38X18
• 00613994915955: SPACER X1110081 PER TI XXL 12D 38X20
• 00613994915948: SPACER X1110083 PER TI XXL 15D 38X10
• 00613994915931: SPACER X1110084 PER TI XXL 15D 38X12
• 00613994915924: SPACER X1110085 PER TI XXL 15D 38X14
• 00613994915917: SPACER X1110086 PER TI XXL 15D 38X16
• 00613994915900: SPACER X1110087 PER TI XXL 15D 38X18
• 00613994915894: SPACER X1110088 PER TI XXL 15D 38X20
• 00613994915887: SPACER X1110072 PER TI XXL 8D 38X16
• 00613994915870: SPACER X0910123 PER TI XL 8D 36X14
• 00613994207043: SPACER 3494320 PRMTR XLG 8DEG 20MM
• 00613994207036: SPACER 3494318 PRMTR XLG 8DEG 18MM