Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Transept Cervical Plate System

K-Number: K200927 · 2020-07-24

ApplicantNeurostructures, Inc.
Decision Date2020-07-24
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Transept Cervical Plate System is a medical device manufactured by Neurostructures, Inc.. It received FDA 510(k) clearance on 2020-07-24 under approval number K200927. 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 Transept Cervical Plate System?

Transept Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-07-24. It is manufactured by Neurostructures, Inc.. The 510(k) number is K200927.

When was Transept Cervical Plate System approved by the FDA?

Transept Cervical Plate System received FDA 510(k) clearance on 2020-07-24, under approval number K200927.

What company makes Transept Cervical Plate System?

Transept Cervical Plate System is manufactured by Neurostructures, Inc..

What is the FDA product code for Transept Cervical Plate System?

The FDA product code for Transept Cervical Plate System is KWQ.

Related Clinical Trials

NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN

Other Devices by Neurostructures, Inc.

K153097Belvedere™ Lateral Plating System K171914Cortina™ Lumbar Cage System K171112Trifore(tm) Cervical Plating System K182195Arco™-SA Lumbar Cage System K181590Neurostructures Cavetto® [MAX] Cervical Cage System K173082Arco™-SA Lumbar Cage System

View all 13 devices →

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.

↑