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FDA 510(k)

NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM

K-Number: K011118 · 2001-07-20

ApplicantOsteomedics
Decision Date2001-07-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomedics. It received FDA 510(k) clearance on 2001-07-20 under 510(k) number K011118. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM?

NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-07-20. The listed applicant is Osteomedics. The 510(k) number is K011118.

When did NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM receive FDA 510(k) clearance?

NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM received FDA 510(k) clearance on 2001-07-20, under 510(k) number K011118.

Who is the listed applicant for NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM?

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

What is the FDA product code for NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM?

The FDA product code for NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM is HRS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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