SOLO-L
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Aurora Spine Inc
The following data is part of a premarket notification filed by Aurora Spine Inc with the FDA for Solo-l.
Pre-market Notification Details
| Device ID | K220610 |
| 510k Number | K220610 |
| Device Name: | SOLO-L |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Aurora Spine Inc 1930 Palomar Point Way, Suite #103 Carlsbad, CA 92008 |
| Contact | Laszlo Garamszegi |
| Correspondent | Lucie Dalet RQM+ 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-03 |
| Decision Date | 2022-05-27 |
Trademark Results [SOLO-L]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLO-L 88650650 not registered Live/Pending |
AURORA SPINE, INC. 2019-10-11 |
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