X-Box 8881422

GUDID M71188814220

PEEK, Ta

Innovasis, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: M71188814220
• NIH Device Record Key: b0b8769d-f210-4b59-8988-180b95e17e99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Box
• Version Model Number: 8881422
• Catalog Number: 8881422
• Company DUNS: 156567492
• Company Name: Innovasis, Inc.
• Device Count: 1
• DM Exempt: true
• 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: 801-261-2236
• Email: info@innovasis.com

Device Dimensions

• Width: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M71188814220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062151

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

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

[M71188814220]

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: 2015-01-22

On-Brand Devices [X-Box]

• M711LCI010: SST
• M71190814250: PEEK, Ta
• M71190812250: PEEK, Ta
• M71190810250: PEEK, Ta
• M71190808250: PEEK, Ta
• M71188814250: PEEK, Ta
• M71188814220: PEEK, Ta
• M71188812250: PEEK, Ta
• M71188812220: PEEK, Ta
• M71188810250: PEEK, Ta
• M71188810220: PEEK, Ta
• M71188808250: PEEK, Ta
• M71188808220: PEEK, Ta
• M71188016250: PEEK, Ta
• M71188014250: PEEK, Ta
• M71188012250: PEEK, Ta
• M71188010250: PEEK, Ta
• M71188008250: PEEK, Ta
• M71181014220: PEEK, Ta
• M71181012220: PEEK, Ta
• M71181010220: PEEK, Ta
• M71181008220: PEEK, Ta
• M71180814220: PEEK, Ta
• M71180812220: PEEK, Ta
• M71180810220: PEEK, Ta
• M71180808220: PEEK, Ta
• M711LCR010: SST
• M711BTA690: Polypropylene, Radel, SST
• M711BTA680: Polypropylene, Radel, SST
• M711BTA670: Al, SST, Nylon, Silicone
• M711LCS140: SST
• M711LCS130: SST
• M711LCS120: SST
• M711LCS110: SST
• M711LCS100: SST
• M711LCS090: SST
• M711LCS080: SST
• M711LCS070: SST
• M711LCD140: SST
• M711LCD130: SST
• M711LCD120: SST
• M711LCD110: SST
• M711LCD100: SST
• M711LCD090: SST
• M711LCD080: SST
• M711LCD070: SST