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FDA 510(k)

Butrex Lumbar Buttress Plating System

K-Number: K170530 · 2017-03-22

ApplicantX-Spine Systems, Inc.
Decision Date2017-03-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Butrex Lumbar Buttress Plating System is a medical device manufactured by X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2017-03-22 under approval number K170530. 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 Butrex Lumbar Buttress Plating System?

Butrex Lumbar Buttress Plating System is a medical device that received FDA 510(k) clearance on 2017-03-22. It is manufactured by X-Spine Systems, Inc.. The 510(k) number is K170530.

When was Butrex Lumbar Buttress Plating System approved by the FDA?

Butrex Lumbar Buttress Plating System received FDA 510(k) clearance on 2017-03-22, under approval number K170530.

What company makes Butrex Lumbar Buttress Plating System?

Butrex Lumbar Buttress Plating System is manufactured by X-Spine Systems, Inc..

What is the FDA product code for Butrex Lumbar Buttress Plating System?

The FDA product code for Butrex Lumbar Buttress Plating 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 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 NCT07214844 A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain RECRUITING

Other Devices by X-Spine Systems, Inc.

K160959Xsert Lumbar Expandable Interbody System K162944Irix-C Cervical Integrated Fusion System K160428Certex Spinal Fixation System K160114Xspan Laminoplasty Fixation System K170119Calix Lumbar Spinal Implant System K171567IRIX-A Lumbar Integrated Fusion 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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