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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 a medical device manufactured by Conventus Orthopaedics, Inc.. It received FDA 510(k) clearance on 2016-07-26 under approval 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. It is manufactured by Conventus Orthopaedics, Inc.. The 510(k) number is K161048.

When was Conventus Orthopaedics Ulna Fixation System approved by the FDA?

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

What company makes Conventus Orthopaedics Ulna Fixation System?

Conventus Orthopaedics Ulna Fixation System is manufactured by Conventus Orthopaedics, Inc..

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

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

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT05304819 PMCF Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING

Related Devices (Code: HRS)

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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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