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)

ANAX™ 5.5 Spinal System

K-Number: K162189 · 2016-08-30

ApplicantU&I Corporation
Decision Date2016-08-30
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANAX™ 5.5 Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corporation. It received FDA 510(k) clearance on 2016-08-30 under 510(k) number K162189. 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 ANAX™ 5.5 Spinal System?

ANAX™ 5.5 Spinal System is a medical device that received FDA 510(k) clearance on 2016-08-30. The listed applicant is U&I Corporation. The 510(k) number is K162189.

When did ANAX™ 5.5 Spinal System receive FDA 510(k) clearance?

ANAX™ 5.5 Spinal System received FDA 510(k) clearance on 2016-08-30, under 510(k) number K162189.

Who is the listed applicant for ANAX™ 5.5 Spinal System?

The FDA 510(k) record lists U&I Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANAX™ 5.5 Spinal System?

The FDA product code for ANAX™ 5.5 Spinal System is MNH. This falls under the ENT category.

Other records listing U&I Corporation 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.

K220147Aspiron S ACP SystemK210573Velofix SA Cervical CageK183243Velofix TLIF CageK190067Velofix Interbody Fusion SystemK190053SECULOK™ ACP SystemK181824CBT Screw Fixation System

View all 16 devices →

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.K151362HC 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.

↑