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FDA 510(k)

ROSA Spine

K-Number: K151511 · 2016-01-04

ApplicantMedtech S.A
Decision Date2016-01-04
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ROSA Spine is a medical device manufactured by Medtech S.A. It received FDA 510(k) clearance on 2016-01-04 under approval number K151511. 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 Spine?

ROSA Spine is a medical device that received FDA 510(k) clearance on 2016-01-04. It is manufactured by Medtech S.A. The 510(k) number is K151511.

When was ROSA Spine approved by the FDA?

ROSA Spine received FDA 510(k) clearance on 2016-01-04, under approval number K151511.

What company makes ROSA Spine?

ROSA Spine is manufactured by Medtech S.A.

What is the FDA product code for ROSA Spine?

The FDA product code for ROSA Spine is OLO.

Other Devices by Medtech S.A

K172444ROSA BRAIN (v3.0.0.5) K192173ROSA ONE Spine application 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

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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