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FDA 510(k)

MODIFICATION TO XIA SPINE SYSTEM

K-Number: K012027 · 2001-07-20

ApplicantHowmedica Osteonics
Decision Date2001-07-20
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO XIA SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics. It received FDA 510(k) clearance on 2001-07-20 under 510(k) number K012027. 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 MODIFICATION TO XIA SPINE SYSTEM?

MODIFICATION TO XIA SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2001-07-20. The listed applicant is Howmedica Osteonics. The 510(k) number is K012027.

When did MODIFICATION TO XIA SPINE SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO XIA SPINE SYSTEM received FDA 510(k) clearance on 2001-07-20, under 510(k) number K012027.

Who is the listed applicant for MODIFICATION TO XIA SPINE SYSTEM?

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

What is the FDA product code for MODIFICATION TO XIA SPINE SYSTEM?

The FDA product code for MODIFICATION TO XIA SPINE SYSTEM is MNH. This falls under the ENT category.

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Related Devices (Code: MNH)

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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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