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FDA 510(k)

MODIFICATION TO OPUS SPINAL SYSTEM

K-Number: K014229 · 2002-01-25

ApplicantHowmedica Osteonics Corp.
Decision Date2002-01-25
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO OPUS SPINAL SYSTEM 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 2002-01-25 under 510(k) number K014229. 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 OPUS SPINAL SYSTEM?

MODIFICATION TO OPUS SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-25. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K014229.

When did MODIFICATION TO OPUS SPINAL SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO OPUS SPINAL SYSTEM received FDA 510(k) clearance on 2002-01-25, under 510(k) number K014229.

Who is the listed applicant for MODIFICATION TO OPUS SPINAL SYSTEM?

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 MODIFICATION TO OPUS SPINAL SYSTEM?

The FDA product code for MODIFICATION TO OPUS SPINAL 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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