FDA 510(k)

ROSA ONE Spine application

K-Number: K192173 · 2019-10-29

Decision Date2019-10-29

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ROSA ONE Spine application is a medical device manufactured by Medtech S.A. It received FDA 510(k) clearance on 2019-10-29 under approval number K192173. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROSA ONE Spine application?

ROSA ONE Spine application is a medical device that received FDA 510(k) clearance on 2019-10-29. It is manufactured by Medtech S.A. The 510(k) number is K192173.

When was ROSA ONE Spine application approved by the FDA?

ROSA ONE Spine application received FDA 510(k) clearance on 2019-10-29, under approval number K192173.

What company makes ROSA ONE Spine application?

ROSA ONE Spine application is manufactured by Medtech S.A.

What is the FDA product code for ROSA ONE Spine application?

The FDA product code for ROSA ONE Spine application is OLO.

Related Clinical Trials

NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION

Other Devices by Medtech S.A

K151511ROSA Spine K172444ROSA BRAIN (v3.0.0.5) K182848ROSA ONE Spine application K182417ROSA ONE Brain Application K200511ROSA ONE Brain application

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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.