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FDA 510(k)

Zavation Spinal System

K-Number: K153404 · 2016-04-21

ApplicantZavation, LLC
Decision Date2016-04-21
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zavation Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation, LLC. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K153404. 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 Zavation Spinal System?

Zavation Spinal System is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Zavation, LLC. The 510(k) number is K153404.

When did Zavation Spinal System receive FDA 510(k) clearance?

Zavation Spinal System received FDA 510(k) clearance on 2016-04-21, under 510(k) number K153404.

Who is the listed applicant for Zavation Spinal System?

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

What is the FDA product code for Zavation Spinal System?

The FDA product code for Zavation Spinal System is MNH. This falls under the ENT category.

Other records listing Zavation, LLC 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.

K162206Zavation IBFK162575Z-LINKPC SystemK162824Z-Span Plate SystemK161016Z-Clamp ISP SystemK160362Z-Span Plate 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.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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