Ventana L Spinal System
K-Number: K231252 · 2023-06-30
ApplicantSpinal Elements, Inc.
Decision Date2023-06-30
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Ventana L Spinal System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2023-06-30 under approval number K231252. 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 Ventana L Spinal System?
Ventana L Spinal System is a medical device that received FDA 510(k) clearance on 2023-06-30. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K231252.
When was Ventana L Spinal System approved by the FDA?
Ventana L Spinal System received FDA 510(k) clearance on 2023-06-30, under approval number K231252.
What company makes Ventana L Spinal System?
Ventana L Spinal System is manufactured by Spinal Elements, Inc..
What is the FDA product code for Ventana L Spinal System?
The FDA product code for Ventana L Spinal System is MAX.
Related Clinical Trials
NCT06998134
Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults
RECRUITING
NCT03053791
Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait
RECRUITING
NCT07616050
Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients
NOT_YET_RECRUITING
NCT05508360
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
RECRUITING
NCT06087445
A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia
COMPLETED
NCT07603258
Access-H20: Sensor-driven Smart Faucet Related Study
COMPLETED
Related PubMed Literature
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.