Aurora Spine 108-32210-014
GUDID B521108322100140
ECHO, TRIAL-P, 22mm, 10mm, 14mm
AURORA SPINE, INC.
Polymeric spinal fusion cage, sterile| Primary Device ID | B521108322100140 |
| NIH Device Record Key | d8b9b815-804f-4ac3-bfa4-5c7caa782ab0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aurora Spine |
| Version Model Number | ECHO |
| Catalog Number | 108-32210-014 |
| Company DUNS | 079119091 |
| Company Name | AURORA SPINE, INC. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 760.424.2004 |
| info@auroraspine.us |
Device Dimensions
| Length | 22 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B521108322100140 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133967
FDA Product Code
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B521108322100140]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-08 |
| Device Publish Date | 2019-04-30 |
On-Brand Devices [Aurora Spine]
| B521112028120817UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 17mm, UNCOATED |
| B521112028120816UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 16mm, UNCOATED |
| B521112028120815UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 15mm, UNCOATED |
| B521112028120814UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 14mm, UNCOATED |
| B521112028120813UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 13mm, UNCOATED |
| B521112028120812UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 12mm, UNCOATED |
| B521112028120811UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 11mm, UNCOATED |
| B521112028120810UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 10mm, UNCOATED |
| B521112028120809UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 9mm, UNCOATED |
| B521112028120808UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 8mm, UNCOATED |
| B521112028120417UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 17mm, UNCOATED |
| B521112028120416UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 16mm, UNCOATED |
| B521112028120415UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 15mm, UNCOATED |
| B521112028120414UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 14mm, UNCOATED |
| B521112028120413UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 13mm, UNCOATED |
| B521112028120412UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 12mm, UNCOATED |
| B521112028120411UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 11mm, UNCOATED |
| B521112028120410UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 10mm, UNCOATED |
| B521112028120409UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 9mm, UNCOATED |
| B521112028120408UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 8mm, UNCOATED |
| B521112028120407UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 4 degrees x 7mm, UNCOATED |
| B521112028120017UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 17mm, UNCOATED |
| B521112028120016UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 16mm, UNCOATED |
| B521112028120015UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 15mm, UNCOATED |
| B521112028120014UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 14mm, UNCOATED |
| B521112028120013UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 13mm, UNCOATED |
| B521112028120012UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 12mm, UNCOATED |
| B521112028120011UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 11mm, UNCOATED |
| B521112028120010UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 10mm, UNCOATED |
| B521112028120009UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 9mm, UNCOATED |
| B521112028120008UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 8mm, UNCOATED |
| B521112028120007UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 0 degrees x 7mm, UNCOATED |
| B521112028100817UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 17mm, UNCOATED |
| B521112028100816UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 16mm, UNCOATED |
| B521112028100815UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 15mm, UNCOATED |
| B521112028100814UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 14mm, UNCOATED |
| B521112028100813UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 13mm, UNCOATED |
| B521112028100812UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 12mm, UNCOATED |
| B521112028100811UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 11mm, UNCOATED |
| B521112028100810UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 10mm, UNCOATED |
| B521112028100809UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 9mm, UNCOATED |
| B521112028100808UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 8 degrees x 8mm, UNCOATED |
| B521112028100417UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 17mm, UNCOATED |
| B521112028100416UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 16mm, UNCOATED |
| B521112028100415UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 15mm, UNCOATED |
| B521112028100414UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 14mm, UNCOATED |
| B521112028100413UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 13mm, UNCOATED |
| B521112028100412UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 12mm, UNCOATED |
| B521112028100411UC0 | ECHO SD Lumbar Interbody Fusion System, 28mm x 10mm x 4 degrees x 11mm, UNCOATED |
| B521112028100410UC0 | ECHO 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 86221570 4737651 Live/Registered |
Aurora Spine Inc. 2014-03-14 |
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