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FDA 510(k)

Shanghai Sanyou CARMEN Cervical Fusion System

K-Number: K163366 · 2017-10-05

ApplicantShanghai Sanyou Medical Co, Ltd.
Decision Date2017-10-05
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Shanghai Sanyou CARMEN Cervical Fusion System is a medical device manufactured by Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2017-10-05 under approval number K163366. 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 Shanghai Sanyou CARMEN Cervical Fusion System?

Shanghai Sanyou CARMEN Cervical Fusion System is a medical device that received FDA 510(k) clearance on 2017-10-05. It is manufactured by Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K163366.

When was Shanghai Sanyou CARMEN Cervical Fusion System approved by the FDA?

Shanghai Sanyou CARMEN Cervical Fusion System received FDA 510(k) clearance on 2017-10-05, under approval number K163366.

What company makes Shanghai Sanyou CARMEN Cervical Fusion System?

Shanghai Sanyou CARMEN Cervical Fusion System is manufactured by Shanghai Sanyou Medical Co, Ltd..

What is the FDA product code for Shanghai Sanyou CARMEN Cervical Fusion System?

The FDA product code for Shanghai Sanyou CARMEN Cervical Fusion System is KWQ.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING 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 NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING 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

Other Devices by Shanghai Sanyou Medical Co, Ltd.

K152781Adena-Zina System K163422Shanghai Sanyou PEEK Cage System K211689KEYSTONE PEEK Cage System K212066Adena-Zina System K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System K230961Zeus 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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