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FDA 510(k)

Spinal fixation system

K-Number: K161151 · 2016-09-21

ApplicantCanwell Medical Co., Ltd.
Decision Date2016-09-21
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spinal fixation system is the device name listed in this FDA 510(k) record. The listed applicant is Canwell Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-09-21 under 510(k) number K161151. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spinal fixation system?

Spinal fixation system is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Canwell Medical Co., Ltd.. The 510(k) number is K161151.

When did Spinal fixation system receive FDA 510(k) clearance?

Spinal fixation system received FDA 510(k) clearance on 2016-09-21, under 510(k) number K161151.

Who is the listed applicant for Spinal fixation system?

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

What is the FDA product code for Spinal fixation system?

The FDA product code for Spinal fixation system is MNH. This falls under the ENT category.

Other records listing Canwell 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.

K242973CanMINI Hand and Foot System

Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.K153404Zavation Spinal SystemZavation, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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