Texas Sidewinder

GUDID B014T3015

EMINENT SPINE LLC

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: B014T3015
• NIH Device Record Key: 2bb2d48f-f692-4f6c-9de1-d132c8a0cdc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Texas Sidewinder
• Version Model Number: T3015
• Company DUNS: 022576742
• Company Name: EMINENT SPINE LLC
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B014T3015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090064

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

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

[B014T3015]

Moist Heat or Steam Sterilization

[B014T3015]

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: 2017-02-09

On-Brand Devices [Texas Sidewinder]

• B014T4016: T4016
• B014T4015: T4015
• B014T4014: T4014
• B014T4013: T4013
• B014T4012: T4012
• B014T4011: T4011
• B014T4010: T4010
• B014T4009: T4009
• B014T4008: T4008
• B014T4007: T4007
• B014T3016: T3016
• B014T3015: T3015
• B014T3014: T3014
• B014T3013: T3013
• B014T3012: T3012
• B014T3011: T3011
• B014T3010: T3010
• B014T3009: T3009
• B014T3008: T3008
• B014T3007: T3007