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FDA 510(k)

RESTORATION ADM SYSTEM

K-Number: K072020 · 2007-10-18

ApplicantHowmedica Osteonics Corp.
Decision Date2007-10-18
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RESTORATION ADM 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 2007-10-18 under 510(k) number K072020. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTORATION ADM SYSTEM?

RESTORATION ADM SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-18. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K072020.

When did RESTORATION ADM SYSTEM receive FDA 510(k) clearance?

RESTORATION ADM SYSTEM received FDA 510(k) clearance on 2007-10-18, under 510(k) number K072020.

Who is the listed applicant for RESTORATION ADM 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 RESTORATION ADM SYSTEM?

The FDA product code for RESTORATION ADM SYSTEM is MEH.

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Related Devices (Code: MEH)

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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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