FDA 510(k)

Reliance Lumbar IBF System

K-Number: K173283 · 2018-01-19

Decision Date2018-01-19

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Reliance Lumbar IBF System is a medical device manufactured by Reliance Medical Systems, LLC. It received FDA 510(k) clearance on 2018-01-19 under approval number K173283. 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 Reliance Lumbar IBF System?

Reliance Lumbar IBF System is a medical device that received FDA 510(k) clearance on 2018-01-19. It is manufactured by Reliance Medical Systems, LLC. The 510(k) number is K173283.

When was Reliance Lumbar IBF System approved by the FDA?

Reliance Lumbar IBF System received FDA 510(k) clearance on 2018-01-19, under approval number K173283.

What company makes Reliance Lumbar IBF System?

Reliance Lumbar IBF System is manufactured by Reliance Medical Systems, LLC.

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

The FDA product code for Reliance 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 NCT07531901 Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid NOT_YET_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

Other Devices by Reliance Medical Systems, LLC

K162066Reliance Spinal Screw System K160463Reliance Lumbar IBF System K173102Reliance Cervical IBF System K172489Reliance Cervical IBF System K183049Reliance Lumbar IBF System K210874Reliance Spinal Screw System

View all 8 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.