FDA 510(k)

LumiVy Lumbar IBF System

K-Number: K223412 · 2023-01-06

Decision Date2023-01-06

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LumiVy Lumbar IBF System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2023-01-06 under approval number K223412. 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 LumiVy Lumbar IBF System?

LumiVy Lumbar IBF System is a medical device that received FDA 510(k) clearance on 2023-01-06. It is manufactured by Vy Spine, LLC. The 510(k) number is K223412.

When was LumiVy Lumbar IBF System approved by the FDA?

LumiVy Lumbar IBF System received FDA 510(k) clearance on 2023-01-06, under approval number K223412.

What company makes LumiVy Lumbar IBF System?

LumiVy Lumbar IBF System is manufactured by Vy Spine, LLC.

What is the FDA product code for LumiVy Lumbar IBF System?

The FDA product code for LumiVy Lumbar IBF System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING NCT07494812 Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials NOT_YET_RECRUITING NCT07214844 A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain RECRUITING

Other Devices by Vy Spine, LLC

K213219Vy Spine VyWasher Buttress System K212715Vy Spine ClariVy Cervical IBF System K213394Vy Spine VySpan PCT System K221162UniVy OsteoVy Cervical IBF System K221572VyPlate Anterior Cervical Plate System K213750VyLink Spinal Screw System

View all 21 devices →

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.