PLIF - Posterior Lumbar Interbody Fusion Sysytem

GUDID 00814008021109

10x30 15mm 6 Degree

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: 00814008021109
• NIH Device Record Key: 52e0dd3e-3ff9-4fb5-b7b3-7e323918e1f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLIF - Posterior Lumbar Interbody Fusion Sysytem
• Version Model Number: PL-615-L
• Company DUNS: 047486041
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, 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: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com

Device Dimensions

• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814008021109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142594

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00814008021109]

Moist Heat or Steam Sterilization

[00814008021109]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-10-19

On-Brand Devices [PLIF - Posterior Lumbar Interbody Fusion Sysytem]

• 00814008021109: 10x30 15mm 6 Degree
• 00814008021093: 10x30 14mm 6 Degree
• 00814008021086: 10x30 13mm 6 Degree
• 00814008021079: 10x30 12mm 6 Degree
• 00814008021062: 10x30 11mm 6 Degree
• 00814008021055: 10x30 10mm 6 Degree
• 00814008021048: 10x30 9mm 6 Degree
• 00814008021031: 10x30 8mm 6 Degree
• 00814008021024: 10x30 7mm 6 Degree
• 00814008021017: 10x30 15mm 0 Degree
• 00814008021000: 10x30 14mm 0 Degree
• 00814008020997: 10x30 13mm 0 Degree
• 00814008020980: 10x30 12mm 0 Degree
• 00814008020973: 10x30 11mm 0 Degree
• 00814008020966: 10x30 10mm 0 Degree
• 00814008020959: 10x30 9mm 0 Degree
• 00814008020942: 10x30 8mm 0 Degree
• 00814008020935: 10x30 7mm 0 Degree
• 00814008020928: 10x30 6mm 0 Degree
• 00814008020911: 10x26 15mm 6 Degree
• 00814008020904: 10x26 14mm 6 Degree
• 00814008020898: 10x26 13mm 6 Degree
• 00814008020881: 10x26 12mm 6 Degree
• 00814008020874: 10x26 11mm 6 Degree
• 00814008020867: 10x26 10mm 6 Degree
• 00814008020850: 10x26 9mm 6 Degree
• 00814008020843: 10x26 8mm 6 Degree
• 00814008020836: 10x26 7mm 6 Degree
• 00814008020829: 10x26 15mm 0 Degrees
• 00814008020812: 10x26 14mm 0 Degrees
• 00814008020805: 10x26 13mm 0 Degrees
• 00814008020799: 10x26 12mm 0 Degrees
• 00814008020782: 10x26 11mm 0 Degrees
• 00814008020775: 10x26 10mm 0 Degrees
• 00814008020768: 10x26 9mm 0 Degrees
• 00814008020751: 10x26 8mm 0 Degrees
• 00814008020744: 10x26 7mm 0 Degrees
• 00814008020737: 10x26 6mm 0 Degrees
• 00814008020720: 10x22 15mm 0 Degrees
• 00814008020713: 10x22 14mm 0 Degrees
• 00814008020706: 10x22 13mm 0 Degrees
• 00814008020690: 10x22 12mm 0 Degrees
• 00814008020683: 10x22 11mm 0 Degrees
• 00814008020676: 10x22 10mm 0 Degrees
• 00814008020669: 10x22 9mm 0 Degrees
• 00814008020652: 10x22 8mm 0 Degrees
• 00814008020645: 10x22 7mm 0 Degrees
• 00814008020638: 10x22 6mm 0 Degrees