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FDA 510(k)

Conventus Orthopaedics Ulna Fixation System

K-Number: K161048 · 2016-07-26

ApplicantConventus Orthopaedics, Inc.
Decision Date2016-07-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Conventus Orthopaedics Ulna Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Conventus Orthopaedics, Inc.. It received FDA 510(k) clearance on 2016-07-26 under 510(k) number K161048. 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 Conventus Orthopaedics Ulna Fixation System?

Conventus Orthopaedics Ulna Fixation System is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Conventus Orthopaedics, Inc.. The 510(k) number is K161048.

When did Conventus Orthopaedics Ulna Fixation System receive FDA 510(k) clearance?

Conventus Orthopaedics Ulna Fixation System received FDA 510(k) clearance on 2016-07-26, under 510(k) number K161048.

Who is the listed applicant for Conventus Orthopaedics Ulna Fixation System?

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

What is the FDA product code for Conventus Orthopaedics Ulna Fixation System?

The FDA product code for Conventus Orthopaedics Ulna Fixation System is HRS.

Other records listing Conventus Orthopaedics, Inc. as applicant

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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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