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FDA 510(k)

Reliance Lumbar IBF System

K-Number: K181118 · 2019-01-09

ApplicantReliance Medical Systems
Decision Date2019-01-09
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Reliance Lumbar IBF System is a medical device manufactured by Reliance Medical Systems. It received FDA 510(k) clearance on 2019-01-09 under approval number K181118. The device is classified under product code OVD. 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 2019-01-09. It is manufactured by Reliance Medical Systems. The 510(k) number is K181118.

When was Reliance Lumbar IBF System approved by the FDA?

Reliance Lumbar IBF System received FDA 510(k) clearance on 2019-01-09, under approval number K181118.

What company makes Reliance Lumbar IBF System?

Reliance Lumbar IBF System is manufactured by Reliance Medical Systems.

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

The FDA product code for Reliance Lumbar IBF System is OVD.

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

K180687Reliance Lumber IBF System

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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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