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FDA 510(k)

MODIFICATION TO RESTORATION MODULAR SYSTEM

K-Number: K040734 · 2004-08-25

ApplicantHowmedica Osteonics Corp.
Decision Date2004-08-25
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO RESTORATION MODULAR 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 2004-08-25 under 510(k) number K040734. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO RESTORATION MODULAR SYSTEM?

MODIFICATION TO RESTORATION MODULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2004-08-25. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K040734.

When did MODIFICATION TO RESTORATION MODULAR SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO RESTORATION MODULAR SYSTEM received FDA 510(k) clearance on 2004-08-25, under 510(k) number K040734.

Who is the listed applicant for MODIFICATION TO RESTORATION MODULAR 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 RESTORATION MODULAR SYSTEM?

The FDA product code for MODIFICATION TO RESTORATION MODULAR SYSTEM is LZO.

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Related Devices (Code: LZO)

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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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