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

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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2017-10-05 under 510(k) 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. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K163366.

When did Shanghai Sanyou CARMEN Cervical Fusion System receive FDA 510(k) clearance?

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

Who is the listed applicant for Shanghai Sanyou CARMEN Cervical Fusion System?

The FDA 510(k) record lists Shanghai Sanyou Medical Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Shanghai Sanyou Medical Co, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage SystemK230961Zeus Spinal SystemK231931Adena-Zina Spinal SystemK211689KEYSTONE PEEK Cage SystemK212066Adena-Zina SystemK163422Shanghai Sanyou PEEK Cage System

View all 8 devices →

Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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.

↑