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FDA 510(k)

Reliance Lumber IBF System

K-Number: K180687 · 2018-05-15

ApplicantReliance Medical Systems
Decision Date2018-05-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Reliance Lumber IBF System is a medical device manufactured by Reliance Medical Systems. It received FDA 510(k) clearance on 2018-05-15 under approval number K180687. 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 Lumber IBF System?

Reliance Lumber IBF System is a medical device that received FDA 510(k) clearance on 2018-05-15. It is manufactured by Reliance Medical Systems. The 510(k) number is K180687.

When was Reliance Lumber IBF System approved by the FDA?

Reliance Lumber IBF System received FDA 510(k) clearance on 2018-05-15, under approval number K180687.

What company makes Reliance Lumber IBF System?

Reliance Lumber IBF System is manufactured by Reliance Medical Systems.

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

The FDA product code for Reliance Lumber IBF System is MAX.

Related Clinical Trials

NCT07531901 Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid NOT_YET_RECRUITING NCT04462250 Mobile Health (mHealth) App for Safe Opioid Use WITHDRAWN NCT07495254 Effectiveness of Combined Super Inductive System (SIS) Therapy With Therapeutic Exercise and Health Education in Lateral Elbow Tendinopathy NOT_YET_RECRUITING

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024)

Other Devices by Reliance Medical Systems

K181118Reliance Lumbar IBF System

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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