Texas Python

GUDID B014P1009

EMINENT SPINE LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: B014P1009
• NIH Device Record Key: 8a766beb-d963-427b-b81d-521dd6e519f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Texas Python
• Version Model Number: P1009
• 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	B014P1009 [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

[B014P1009]

Moist Heat or Steam Sterilization

[B014P1009]

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 Python]

• B014PL4016: PL4016
• B014PL4015: PL4015
• B014PL4014: PL4014
• B014PL4013: PL4013
• B014PL4012: PL4012
• B014PL4011: PL4011
• B014PL4010: PL4010
• B014PL4009: PL4009
• B014PL4008: PL4008
• B014P6016: P6016
• B014P6015: P6015
• B014P6014: P6014
• B014P6013: P6013
• B014P6012: P6012
• B014P6011: P6011
• B014P6010: P6010
• B014P6009: P6009
• B014P6008: P6008
• B014P5016: P5016
• B014P5015: P5015
• B014P5014: P5014
• B014P5013: P5013
• B014P5012: P5012
• B014P5011: P5011
• B014P5010: P5010
• B014P5009: P5009
• B014P5008: P5008
• B014P3016: P3016
• B014P3015: P3015
• B014P3014: P3014
• B014P3013: P3013
• B014P3012: P3012
• B014P3011: P3011
• B014P3010: P3010
• B014P3009: P3009
• B014P3008: P3008
• B014P3007: P3007
• B014P2513: P2513
• B014P2512: P2512
• B014P2511: P2511
• B014P2510: P2510
• B014P2508: P2508
• B014P2016: P2016
• B014P2015: P2015
• B014P2014: P2014
• B014P2013: P2013
• B014P2012: P2012
• B014P2011: P2011
• B014P2010: P2010
• B014P2009: P2009