IMPIX ALIF S/A B15221409

GUDID 03613720194927

IMPIX-ALIF S/A Large 14mm x 9°

MEDICREA INTERNATIONAL

Polymeric spinal interbody fusion cage
Primary Device ID03613720194927
NIH Device Record Key3dab3902-89db-4c18-b06d-e3a464f25c14
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMPIX ALIF S/A
Version Model NumberB15221409
Catalog NumberB15221409
Company DUNS383228632
Company NameMEDICREA INTERNATIONAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103613720194927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-08-06
Device Publish Date2015-10-23

On-Brand Devices [IMPIX ALIF S/A]

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