Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OSSEODUO Shaver and Drill System

K-Number: K173066 · 2018-06-22

ApplicantBien-Air Surgery SA
Decision Date2018-06-22
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OSSEODUO Shaver and Drill System is the device name listed in this FDA 510(k) record. The listed applicant is Bien-Air Surgery SA. It received FDA 510(k) clearance on 2018-06-22 under 510(k) 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. The listed applicant is Bien-Air Surgery SA. The 510(k) number is K173066.

When did OSSEODUO Shaver and Drill System receive FDA 510(k) clearance?

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

Who is the listed applicant for OSSEODUO Shaver and Drill System?

The FDA 510(k) record lists Bien-Air Surgery SA as the applicant. This does not by itself establish the device manufacturer.

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 records listing Bien-Air Surgery SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221184ORiGO SystemK213697ORiGO System

Related Devices (Code: HBC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.K213697ORiGO SystemBien-Air Surgery SAK220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc.K193630hekaDrillZethon, Ltd.K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions

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.

↑