Aurora Spine 108-32212-012

GUDID B521108322120120

ECHO, TRIAL-P, 22mm, 12mm, 12mm

AURORA SPINE, INC.

Polymeric spinal fusion cage, sterile
Primary Device IDB521108322120120
NIH Device Record Keyfa0530f0-913a-4da4-a6be-7e78dbcfd59a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAurora Spine
Version Model NumberECHO
Catalog Number108-32212-012
Company DUNS079119091
Company NameAURORA SPINE, INC.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone760.424.2004
Emailinfo@auroraspine.us

Device Dimensions

Length22 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB521108322120120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B521108322120120]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-08
Device Publish Date2019-04-30

On-Brand Devices [Aurora Spine]

B521112028120817UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 17mm, UNCOATED
B521112028120816UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 16mm, UNCOATED
B521112028120815UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 15mm, UNCOATED
B521112028120814UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 14mm, UNCOATED
B521112028120813UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 13mm, UNCOATED
B521112028120812UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 12mm, UNCOATED
B521112028120811UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 11mm, UNCOATED
B521112028120810UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 10mm, UNCOATED
B521112028120809UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 9mm, UNCOATED
B521112028120808UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 8mm, UNCOATED
B521112028120417UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 17mm, UNCOATED
B521112028120416UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 16mm, UNCOATED
B521112028120415UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 15mm, UNCOATED
B521112028120414UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 14mm, UNCOATED
B521112028120413UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 13mm, UNCOATED
B521112028120412UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 12mm, UNCOATED
B521112028120411UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 11mm, UNCOATED
B521112028120410UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 10mm, UNCOATED
B521112028120409UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 9mm, UNCOATED
B521112028120408UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 8mm, UNCOATED
B521112028120407UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 7mm, UNCOATED
B521112028120017UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 17mm, UNCOATED
B521112028120016UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 16mm, UNCOATED
B521112028120015UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 15mm, UNCOATED
B521112028120014UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 14mm, UNCOATED
B521112028120013UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 13mm, UNCOATED
B521112028120012UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 12mm, UNCOATED
B521112028120011UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 11mm, UNCOATED
B521112028120010UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 10mm, UNCOATED
B521112028120009UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 9mm, UNCOATED
B521112028120008UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 8mm, UNCOATED
B521112028120007UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 7mm, UNCOATED
B521112028100817UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 17mm, UNCOATED
B521112028100816UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 16mm, UNCOATED
B521112028100815UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 15mm, UNCOATED
B521112028100814UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 14mm, UNCOATED
B521112028100813UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 13mm, UNCOATED
B521112028100812UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 12mm, UNCOATED
B521112028100811UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 11mm, UNCOATED
B521112028100810UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 10mm, UNCOATED
B521112028100809UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 9mm, UNCOATED
B521112028100808UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 8mm, UNCOATED
B521112028100417UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 17mm, UNCOATED
B521112028100416UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 16mm, UNCOATED
B521112028100415UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 15mm, UNCOATED
B521112028100414UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 14mm, UNCOATED
B521112028100413UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 13mm, UNCOATED
B521112028100412UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 12mm, UNCOATED
B521112028100411UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 11mm, UNCOATED
B521112028100410UC0ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 10mm, UNCOATED

Trademark Results [Aurora Spine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AURORA SPINE
AURORA SPINE
86221570 4737651 Live/Registered
Aurora Spine Inc.
2014-03-14

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