IMPIX ALIF B15111612

GUDID 03613720193463

IMPIX-ALIF 16 mm at 12°

MEDICREA INTERNATIONAL

Polymeric spinal interbody fusion cage

• Primary Device ID: 03613720193463
• NIH Device Record Key: 901fdccf-f736-4b1b-871f-b303591768a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPIX ALIF
• Version Model Number: B15111612
• Catalog Number: B15111612
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• 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: false
• Expiration Date: true
• 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
GS1	03613720193463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083798

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: 5
• Public Version Date: 2020-08-05
• Device Publish Date: 2015-10-23

On-Brand Devices [IMPIX ALIF]

• 03613720193500: IMPIX-ALIF 20 mm at 6°
• 03613720193456: IMPIX-ALIF 16 mm at 9°
• 03613720193364: IMPIX-ALIF 10 mm at 9°
• 03613720193524: IMPIX-ALIF 20 mm at 12°
• 03613720193517: IMPIX-ALIF 20 mm at 9°
• 03613720193494: IMPIX-ALIF 18 mm at 12°
• 03613720193487: IMPIX-ALIF 18 mm at 9°
• 03613720193470: IMPIX-ALIF 18 mm at 6°
• 03613720193463: IMPIX-ALIF 16 mm at 12°
• 03613720193449: IMPIX-ALIF 16 mm at 6°
• 03613720193432: IMPIX-ALIF 14 mm at 12°
• 03613720193425: IMPIX-ALIF 14 mm at 9°
• 03613720193418: IMPIX-ALIF 14 mm at 6°
• 03613720193401: IMPIX-ALIF 12mm at 12°
• 03613720193395: IMPIX-ALIF 12mm at 9°
• 03613720193388: IMPIX-ALIF 12 mm at 6°
• 03613720193371: IMPIX-ALIF 10 mm at 12°
• 03613720193357: IMPIX-ALIF 10 mm at 6°