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FDA 510(k)

VICTORY™ Lumbar Plate System

K-Number: K232318 · 2023-10-31

ApplicantGlobus Medical, Inc.
Decision Date2023-10-31
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VICTORY™ Lumbar Plate System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2023-10-31 under approval number K232318. 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 VICTORY™ Lumbar Plate System?

VICTORY™ Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2023-10-31. It is manufactured by Globus Medical, Inc.. The 510(k) number is K232318.

When was VICTORY™ Lumbar Plate System approved by the FDA?

VICTORY™ Lumbar Plate System received FDA 510(k) clearance on 2023-10-31, under approval number K232318.

What company makes VICTORY™ Lumbar Plate System?

VICTORY™ Lumbar Plate System is manufactured by Globus Medical, Inc..

What is the FDA product code for VICTORY™ Lumbar Plate System?

The FDA product code for VICTORY™ 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 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 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 Globus Medical, Inc.

K161379ELSA Spacers K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments K160597INDEPENDENCE MIS Spacers K161223TransContinental® M Spacers and InterContinental® Plate-Spacers K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer K151665SUSTAIN Additional Implants

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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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