Scarlet AL-T
K-Number: K181818 · 2018-10-09
ApplicantSpineart
Decision Date2018-10-09
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Scarlet AL-T is a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2018-10-09 under approval number K181818. 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 Scarlet AL-T?
Scarlet AL-T is a medical device that received FDA 510(k) clearance on 2018-10-09. It is manufactured by Spineart. The 510(k) number is K181818.
When was Scarlet AL-T approved by the FDA?
Scarlet AL-T received FDA 510(k) clearance on 2018-10-09, under approval number K181818.
What company makes Scarlet AL-T?
Scarlet AL-T is manufactured by Spineart.
What is the FDA product code for Scarlet AL-T?
The FDA product code for Scarlet AL-T is OVD.
Other Devices by Spineart
Related Devices (Code: OVD)
K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.
K162351SeaSpine® Vu aPOD 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.