IMPIX ALIF

GUDID 03613720193500

IMPIX-ALIF 20 mm at 6°

MEDICREA INTERNATIONAL

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: 03613720193500
• NIH Device Record Key: c759c167-7252-412b-b66d-65cbdac171ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPIX ALIF
• Version Model Number: B15112006
• 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	03613720193500 [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: 2020-08-04
• 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°