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FDA 510(k)

RODIN™ Expandable Lumbar Cage System

K-Number: K231359 · 2023-06-09

ApplicantCtl Medical Corporation
Decision Date2023-06-09
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RODIN™ Expandable Lumbar Cage System is a medical device manufactured by Ctl Medical Corporation. It received FDA 510(k) clearance on 2023-06-09 under approval number K231359. 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 RODIN™ Expandable Lumbar Cage System?

RODIN™ Expandable Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2023-06-09. It is manufactured by Ctl Medical Corporation. The 510(k) number is K231359.

When was RODIN™ Expandable Lumbar Cage System approved by the FDA?

RODIN™ Expandable Lumbar Cage System received FDA 510(k) clearance on 2023-06-09, under approval number K231359.

What company makes RODIN™ Expandable Lumbar Cage System?

RODIN™ Expandable Lumbar Cage System is manufactured by Ctl Medical Corporation.

What is the FDA product code for RODIN™ Expandable Lumbar Cage System?

The FDA product code for RODIN™ Expandable Lumbar Cage 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 Ctl Medical Corporation

K162682MATISSE Anterior Cervical Interbody Fusion Cage System K182151MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate K172788MONET™ Anterior Cervical Interbody Fusion Cage System K173185SEURAT™ Universal Pedicle Screw System K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ K192863MONDRIAN Lumbar Interbody Fusion Cage System

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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.

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