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FDA 510(k)

Genesys Spine Binary Lumbar Plate System

K-Number: K173885 · 2018-04-03

ApplicantGenesys Spine
Decision Date2018-04-03
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 2018-04-03 under approval number K173885. 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 2018-04-03. It is manufactured by Genesys Spine. The 510(k) number is K173885.

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

Genesys Spine Binary Lumbar Plate System received FDA 510(k) clearance on 2018-04-03, under approval number K173885.

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)

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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