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FDA 510(k)

XIA SPINE SYSTEM HOOKS

K-Number: K001319 · 2000-05-23

ApplicantHowmedica Osteonics Corp.
Decision Date2000-05-23
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XIA SPINE SYSTEM HOOKS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2000-05-23 under 510(k) number K001319. 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 XIA SPINE SYSTEM HOOKS?

XIA SPINE SYSTEM HOOKS is a medical device that received FDA 510(k) clearance on 2000-05-23. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K001319.

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

XIA SPINE SYSTEM HOOKS received FDA 510(k) clearance on 2000-05-23, under 510(k) number K001319.

Who is the listed applicant for XIA SPINE SYSTEM HOOKS?

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

What is the FDA product code for XIA SPINE SYSTEM HOOKS?

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

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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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