TLIF LITE

GUDID 08057432560871

SINTEA PLUSTEK SRL

Metallic spinal interbody fusion cage

• Primary Device ID: 08057432560871
• NIH Device Record Key: 77feeec9-e76e-423e-9960-9dec4180d07a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TLIF LITE
• Version Model Number: LFC-002PK3211
• Company DUNS: 544150399
• Company Name: SINTEA PLUSTEK SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057432560871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132907

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-10-08

On-Brand Devices [TLIF LITE]

• 08057432560888: LFC-002PK3213
• 08057432560871: LFC-002PK3211
• 08057432560864: LFC-002PK3209
• 08057432560857: LFC-002PK3207