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FDA 510(k)

SOLO-L

K-Number: K220610 · 2022-05-27

ApplicantAurora Spine, Inc.
Decision Date2022-05-27
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOLO-L is a medical device manufactured by Aurora Spine, Inc.. It received FDA 510(k) clearance on 2022-05-27 under approval number K220610. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLO-L?

SOLO-L is a medical device that received FDA 510(k) clearance on 2022-05-27. It is manufactured by Aurora Spine, Inc.. The 510(k) number is K220610.

When was SOLO-L approved by the FDA?

SOLO-L received FDA 510(k) clearance on 2022-05-27, under approval number K220610.

What company makes SOLO-L?

SOLO-L is manufactured by Aurora Spine, Inc..

What is the FDA product code for SOLO-L?

The FDA product code for SOLO-L is OVD.

Other Devices by Aurora Spine, Inc.

K210521DEXA-C Cervical Interbody System K210325APOLLO Anterior Cervical Plate (ACP) System K221047SILO TFX MIS Sacroiliac Joint Fixation System K221399ZIP™ MIS Interspinous Fusion System

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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