PLIF LITE

GUDID 08057432560826

SINTEA PLUSTEK SRL

Metallic spinal interbody fusion cage

• Primary Device ID: 08057432560826
• NIH Device Record Key: 8e781d1c-d857-4a13-ab7f-bbc7ef7269a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLIF LITE
• Version Model Number: LFC-001PK2212
• 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	08057432560826 [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 [PLIF LITE]

• 08057432565722: LFC-001PK2616
• 08057432565715: LFC-001PK2614
• 08057432565708: LFC-001PK2612
• 08057432565692: LFC-001PK2610
• 08057432565685: LFC-001PK2608
• 08057432560840: LFC-001PK2216
• 08057432560833: LFC-001PK2214
• 08057432560826: LFC-001PK2212
• 08057432560819: LFC-001PK2210
• 08057432560802: LFC-001PK2208