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 IDK220610
510k NumberK220610
Device Name:SOLO-L
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Aurora Spine Inc 1930 Palomar Point Way, Suite #103 Carlsbad,  CA  92008
ContactLaszlo Garamszegi
CorrespondentLucie Dalet
RQM+ 2251 San Diego Avenue, Suite B-257 San Diego,  CA  92110
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-03
Decision Date2022-05-27

Trademark Results [SOLO-L]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOLO-L
SOLO-L
88650650 not registered Live/Pending
AURORA SPINE, INC.
2019-10-11

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