FDA 510(k)

OSSEODUO Shaver and Drill System

K-Number: K173066 · 2018-06-22

Decision Date2018-06-22

Product CodeHBC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

OSSEODUO Shaver and Drill System is a medical device manufactured by Bien-Air Surgery SA. It received FDA 510(k) clearance on 2018-06-22 under approval number K173066. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSEODUO Shaver and Drill System?

OSSEODUO Shaver and Drill System is a medical device that received FDA 510(k) clearance on 2018-06-22. It is manufactured by Bien-Air Surgery SA. The 510(k) number is K173066.

When was OSSEODUO Shaver and Drill System approved by the FDA?

OSSEODUO Shaver and Drill System received FDA 510(k) clearance on 2018-06-22, under approval number K173066.

What company makes OSSEODUO Shaver and Drill System?

OSSEODUO Shaver and Drill System is manufactured by Bien-Air Surgery SA.

What is the FDA product code for OSSEODUO Shaver and Drill System?

The FDA product code for OSSEODUO Shaver and Drill System is HBC.

Other Devices by Bien-Air Surgery SA

K221184ORiGO System K213697ORiGO System

Related Devices (Code: HBC)

K152960ELAN 4 Motor SystemAesculap, Inc. K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting toolsMedtronic Powered Surgical Solutions K163565MR8 Drill SystemMedtronic Powered Surgical Solutions K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions K193630hekaDrillZethon, Ltd. K213697ORiGO SystemBien-Air Surgery SA

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.