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FDA 510(k)

ORiGO System

K-Number: K213697 · 2022-10-31

ApplicantBien-Air Surgery SA
Decision Date2022-10-31
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ORiGO 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 2022-10-31 under 510(k) number K213697. 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 ORiGO System?

ORiGO System is a medical device that received FDA 510(k) clearance on 2022-10-31. The listed applicant is Bien-Air Surgery SA. The 510(k) number is K213697.

When did ORiGO System receive FDA 510(k) clearance?

ORiGO System received FDA 510(k) clearance on 2022-10-31, under 510(k) number K213697.

Who is the listed applicant for ORiGO 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 ORiGO System?

The FDA product code for ORiGO 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 SystemK173066OSSEODUO Shaver and Drill 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.K220485Wireless 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 SolutionsK173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA

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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