IMPIX ALIF S/A B15211803

GUDID 03613720227731

IMPIX-ALIF-S/A Medium18mm x 3°

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

• Primary Device ID: 03613720227731
• NIH Device Record Key: 4877ef96-5f95-439c-b5ed-f84e33986fa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPIX ALIF S/A
• Version Model Number: B15211803
• Catalog Number: B15211803
• 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	03613720227731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141187

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, 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: 2020-08-07
• Device Publish Date: 2015-10-23

On-Brand Devices [IMPIX ALIF S/A]

• 03613720236788: Screw set for IMPIX ALIF S/A LARGE Ø5.5mm
• 03613720236771: Screw set for IMPIX ALIF S/A LARGE Ø4.5mm
• 03613720236764: Screw set for IMPIX ALIF S/A MEDIUM Ø5.5mm
• 03613720236757: Screw set for IMPIX ALIF S/A MEDIUM Ø4.5mm
• 03613720236740: Screw set for IMPIX ALIF S/A SMALL Ø5.5mm
• 03613720236733: Screw set for IMPIX ALIF S/A SMALL Ø4.5mm
• 03613720228134: Vis IMPIX ALIF S/A : Ø5.5 Lg: 32 mm
• 03613720228127: Vis IMPIX ALIF S/A : Ø5.5 Lg: 30 mm
• 03613720228110: Vis IMPIX ALIF S/A : Ø5.5 Lg: 28 mm
• 03613720228103: Vis IMPIX ALIF S/A : Ø5.5 Lg: 26 mm
• 03613720227618: IMPIX-ALIF-S/A Small 20mm x 0°
• 03613720227601: IMPIX-ALIF-S/A Small 18mm x 6°
• 03613720227595: IMPIX-ALIF-S/A Small 18mm x 3°
• 03613720227588: IMPIX-ALIF-S/A Small 18mm x 0°
• 03613720227571: IMPIX-ALIF-S/A Small 16mm x 3°
• 03613720227564: IMPIX-ALIF-S/A Small 16mm x 0°
• 03613720227557: IMPIX-ALIF-S/A Small 14mm x 3°
• 03613720227540: IMPIX-ALIF-S/A Small 14mm x 0°
• 03613720227533: IMPIX-ALIF-S/A Small 12mm x 6°
• 03613720227526: IMPIX-ALIF-S/A Small 12mm x 3°
• 03613720227519: IMPIX-ALIF-S/A Small 12mm x 0°
• 03613720227502: IMPIX ALIF S/A Small 10mm x 3°
• 03613720227496: IMPIX ALIF S/A Small 10mm x 0°
• 03613720195283: IMPIX-ALIF S/A SCREW Lg: 22mm Ø 4.5
• 03613720195276: IMPIX-ALIF S/A SCREW Lg: 32mm Ø 4.5
• 03613720195269: IMPIX-ALIF S/A SCREW Lg: 30mm Ø 4.5
• 03613720195245: IMPIX-ALIF S/A SCREW Lg: 26mm Ø 4.5
• 03613720195238: IMPIX-ALIF S/A SCREW Lg: 24mm Ø 4.5
• 03613720195221: IMPIX-ALIF S/A SCREW Lg: 22mm Ø 4.5
• 03613720194996: IMPIX-ALIF S/A Large 16mm x 12°
• 03613720194989: IMPIX-ALIF S/A Large 16mm x 9°
• 03613720194972: IMPIX-ALIF S/A Large 16mm x 6°
• 03613720194934: IMPIX-ALIF S/A Large 14mm x 12°
• 03613720194927: IMPIX-ALIF S/A Large 14mm x 9°
• 03613720194910: IMPIX-ALIF S/A Large 14mm x 6°
• 03613720194873: IMPIX-ALIF S/A Large 12mm x 12°
• 03613720194866: IMPIX-ALIF S/A Large 12mm x 9°
• 03613720194859: IMPIX-ALIF S/A Large 12mm x 6°
• 03613720194811: IMPIX-ALIF S/A Large 10mm x 12°
• 03613720194804: IMPIX-ALIF S/A Large 10mm x 9°
• 03613720194798: IMPIX-ALIF S/A Large 10mm x 6°
• 03613720194743: IMPIX-ALIF S/A Medium 20mm x 15°
• 03613720194736: IMPIX-ALIF S/A Medium 20mm x 12°
• 03613720194729: IMPIX-ALIF S/A Medium 20mm x 9°
• 03613720194699: IMPIX-ALIF S/A Medium 20mm x 0°
• 03613720194682: IMPIX-ALIF S/A Medium 18mm x 15°
• 03613720194675: IMPIX-ALIF S/A Medium 18mm x 12°
• 03613720194668: IMPIX-ALIF S/A Medium 18mm x 9°
• 03613720194620: IMPIX-ALIF S/A Medium 16mm x 15°
• 03613720194613: IMPIX-ALIF S/A Medium 16mm x 12°