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)

Prase-C Anterior Cervical Plate System

K-Number: K211205 · 2021-08-12

ApplicantGbs Commonwealth Co., Ltd.
Decision Date2021-08-12
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Prase-C Anterior Cervical Plate System is a medical device manufactured by Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2021-08-12 under approval number K211205. 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 Prase-C Anterior Cervical Plate System?

Prase-C Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2021-08-12. It is manufactured by Gbs Commonwealth Co., Ltd.. The 510(k) number is K211205.

When was Prase-C Anterior Cervical Plate System approved by the FDA?

Prase-C Anterior Cervical Plate System received FDA 510(k) clearance on 2021-08-12, under approval number K211205.

What company makes Prase-C Anterior Cervical Plate System?

Prase-C Anterior Cervical Plate System is manufactured by Gbs Commonwealth Co., Ltd..

What is the FDA product code for Prase-C Anterior Cervical Plate System?

The FDA product code for Prase-C Anterior Cervical Plate System is KWQ.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT06977035 Nerve Conduction Study for Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on the Janus Kinase Inhibitor Baricitinib RECRUITING

Other Devices by Gbs Commonwealth Co., Ltd.

K182059Prase MIS Spinal System K173645JASPER Spinal Fixation System K192026Peridot Intervertebral body fusion System K190762The JASPER Spinal Fixation System II K202872Prase PEEK Anterior Cervical Interbody Spacer K202878Prase-AP Anterior Cervical Plate System

View all 14 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.

↑