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FDA 510(k)

Genesys Spine Binary® Lumbar Plate System

K-Number: K192678 · 2019-10-24

ApplicantGenesys Spine
Decision Date2019-10-24
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genesys Spine Binary® Lumbar Plate System is a medical device manufactured by Genesys Spine. It received FDA 510(k) clearance on 2019-10-24 under approval number K192678. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Genesys Spine Binary® Lumbar Plate System?

Genesys Spine Binary® Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2019-10-24. It is manufactured by Genesys Spine. The 510(k) number is K192678.

When was Genesys Spine Binary® Lumbar Plate System approved by the FDA?

Genesys Spine Binary® Lumbar Plate System received FDA 510(k) clearance on 2019-10-24, under approval number K192678.

What company makes Genesys Spine Binary® Lumbar Plate System?

Genesys Spine Binary® Lumbar Plate System is manufactured by Genesys Spine.

What is the FDA product code for Genesys Spine Binary® Lumbar Plate System?

The FDA product code for Genesys Spine Binary® Lumbar Plate System is KWQ.

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 NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023) PMID: 26056630 Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. International journal of spine surgery (2015)

Other Devices by Genesys Spine

K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion System K161914Genesys Spine TiLock Cortical Spinal System K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion System K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion System K153123Genesys Spine Apache Interbody Fusion System K172469TiLock Modular Spinal System

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Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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