Lucent®
K-Number: K170235 · 2017-11-29
ApplicantSpinal Elements, Inc.
Decision Date2017-11-29
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Lucent® is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2017-11-29 under approval number K170235. 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®?
Lucent® is a medical device that received FDA 510(k) clearance on 2017-11-29. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K170235.
When was Lucent® approved by the FDA?
Lucent® received FDA 510(k) clearance on 2017-11-29, under approval number K170235.
What company makes Lucent®?
Lucent® is manufactured by Spinal Elements, Inc..
What is the FDA product code for Lucent®?
The FDA product code for Lucent® is MAX.
Other Devices by Spinal Elements, Inc.
Related Devices (Code: MAX)
K163180Hubble IIOrbbo Surgical, LLC
K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc.
K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL
K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP
K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.
K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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.