TiNano 108-83208-0009
GUDID B5211088320800090
ECHO XL Lumbar Interbody Fusion System, 32mm x 8mm x 0 degrees x 9mm
AURORA SPINE, INC.
Polymeric spinal fusion cage, sterile Polymeric spinal fusion cage, sterile| Primary Device ID | B5211088320800090 |
| NIH Device Record Key | 477667b5-8902-439d-94e6-d752c013c238 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TiNano |
| Version Model Number | ECHO XL |
| Catalog Number | 108-83208-0009 |
| 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 | 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 |
Customer Support Contacts
| Phone | 760.424.2004 |
| info@auroraspine.us | |
| Phone | 760.424.2004 |
| info@auroraspine.us |
Device Dimensions
| Height | 9 Millimeter |
| Angle | 0 degree |
| Width | 8 Millimeter |
| Length | 32 Millimeter |
| Height | 9 Millimeter |
| Angle | 0 degree |
| Width | 8 Millimeter |
| Length | 32 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B5211088320800090 [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 | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-03-01 |
On-Brand Devices [TiNano]
| B5211098341205170 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 5 degrees x 17mm |
| B5211098341205160 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 5 degrees x 16mm |
| B5211098341205150 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 5 degrees x 15mm |
| B5211098341205140 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 5 degrees x 14mm |
| B5211098341205130 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 5 degrees x 13mm |
| B5211098341205120 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 5 degrees x 12mm |
| B5211098341205110 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 5 degrees x 11mm |
| B5211098341205100 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 5 degrees x 10mm |
| B5211098341205090 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 5 degrees x 9mm |
| B5211098341205080 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 5 degrees x 8mm |
| B5211098341205070 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 5 degrees x 7mm |
| B5211098341200170 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 0 degrees x 17mm |
| B5211098341200160 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 0 degrees x 16mm |
| B5211098341200150 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 0 degrees x 15mm |
| B5211098341200140 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 0 degrees x 14mm |
| B5211098341200130 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 0 degrees x 13mm |
| B5211098341200120 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 0 degrees x 12mm |
| B5211098341200110 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 0 degrees x 11mm |
| B5211098341200100 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 0 degrees x 10mm |
| B5211098341200090 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 0 degrees x 9mm |
| B5211098341200080 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 0 degrees x 8mm |
| B5211098341200070 | EOS Lumbar Interbody Fusion System, 34mm x 12mm x 0 degrees x 7mm |
| B5211098341005170 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 5 degrees x 17mm |
| B5211098341005160 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 5 degrees x 16mm |
| B5211098341005150 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 5 degrees x 15mm |
| B5211098341005140 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 5 degrees x 14mm |
| B5211098341005130 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 5 degrees x 13mm |
| B5211098341005120 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 5 degrees x 12mm |
| B5211098341005110 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 5 degrees x 11mm |
| B5211098341005100 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 5 degrees x 10mm |
| B5211098341005090 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 5 degrees x 9mm |
| B5211098341005080 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 5 degrees x 8mm |
| B5211098341005070 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 5 degrees x 7mm |
| B5211098341000170 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 0 degrees x 17mm |
| B5211098341000160 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 0 degrees x 16mm |
| B5211098341000150 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 0 degrees x 15mm |
| B5211098341000140 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 0 degrees x 14mm |
| B5211098341000130 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 0 degrees x 13mm |
| B5211098341000120 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 0 degrees x 12mm |
| B5211098341000110 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 0 degrees x 11mm |
| B5211098341000100 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 0 degrees x 10mm |
| B5211098341000090 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 0 degrees x 9mm |
| B5211098341000080 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 0 degrees x 8mm |
| B5211098341000070 | EOS Lumbar Interbody Fusion System, 34mm x 10mm x 0 degrees x 7mm |
| B5211098321205170 | EOS Lumbar Interbody Fusion System, 32mm x 12mm x 5 degrees x 17mm |
| B5211098321205160 | EOS Lumbar Interbody Fusion System, 32mm x 12mm x 5 degrees x 16mm |
| B5211098321205150 | EOS Lumbar Interbody Fusion System, 32mm x 12mm x 5 degrees x 15mm |
| B5211098321205140 | EOS Lumbar Interbody Fusion System, 32mm x 12mm x 5 degrees x 14mm |
| B5211098321205130 | EOS Lumbar Interbody Fusion System, 32mm x 12mm x 5 degrees x 13mm |
| B5211098321205120 | EOS Lumbar Interbody Fusion System, 32mm x 12mm x 5 degrees x 12mm |
Trademark Results [TiNano]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TINANO 97510791 not registered Live/Pending |
Aurora Spine, Inc. 2022-07-19 |
 TINANO 86222165 4666178 Live/Registered |
Aurora Spine Inc. 2014-03-14 |
 TINANO 75924127 2592418 Dead/Cancelled |
Altair Nanomaterials, Inc. 2000-02-22 |
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