Lucent 3D Spinal System
K-Number: K203254 · 2021-03-26
ApplicantSpinal Elements, Inc.
Decision Date2021-03-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Lucent 3D Spinal System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2021-03-26 under approval number K203254. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Lucent 3D Spinal System?
Lucent 3D Spinal System is a medical device that received FDA 510(k) clearance on 2021-03-26. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K203254.
When was Lucent 3D Spinal System approved by the FDA?
Lucent 3D Spinal System received FDA 510(k) clearance on 2021-03-26, under approval number K203254.
What company makes Lucent 3D Spinal System?
Lucent 3D Spinal System is manufactured by Spinal Elements, Inc..
What is the FDA product code for Lucent 3D Spinal System?
The FDA product code for Lucent 3D Spinal System is MAX.
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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.