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FDA 510(k)

TRANSET FRACTURE FIXATION SYSTEM

K-Number: K033717 · 2004-02-25

ApplicantBonutti Research, Inc.
Decision Date2004-02-25
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRANSET FRACTURE FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bonutti Research, Inc.. It received FDA 510(k) clearance on 2004-02-25 under 510(k) number K033717. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSET FRACTURE FIXATION SYSTEM?

TRANSET FRACTURE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-02-25. The listed applicant is Bonutti Research, Inc.. The 510(k) number is K033717.

When did TRANSET FRACTURE FIXATION SYSTEM receive FDA 510(k) clearance?

TRANSET FRACTURE FIXATION SYSTEM received FDA 510(k) clearance on 2004-02-25, under 510(k) number K033717.

Who is the listed applicant for TRANSET FRACTURE FIXATION SYSTEM?

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

What is the FDA product code for TRANSET FRACTURE FIXATION SYSTEM?

The FDA product code for TRANSET FRACTURE FIXATION SYSTEM is HTY.

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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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