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FDA 510(k)

FixxSure® X-Link

K-Number: K162143 · 2016-09-23

ApplicantInnovasis, Inc.
Decision Date2016-09-23
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FixxSure® X-Link is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2016-09-23 under 510(k) number K162143. 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 FixxSure® X-Link?

FixxSure® X-Link is a medical device that received FDA 510(k) clearance on 2016-09-23. The listed applicant is Innovasis, Inc.. The 510(k) number is K162143.

When did FixxSure® X-Link receive FDA 510(k) clearance?

FixxSure® X-Link received FDA 510(k) clearance on 2016-09-23, under 510(k) number K162143.

Who is the listed applicant for FixxSure® X-Link?

The FDA 510(k) record lists Innovasis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FixxSure® X-Link?

The FDA product code for FixxSure® X-Link is MNH. This falls under the ENT category.

Other records listing Innovasis, Inc. as applicant

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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.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.K153404Zavation Spinal SystemZavation, LLC

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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