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ROSA ONE Spine application

by Medtech S.A 2 variants

510(k) K182848

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182848 Date22 Mar 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OLO
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

ROSA ONE Spine application is a stereotaxic instrument. It is classified as a Class II device under product code OLO.

The device received FDA 510(k) clearance (K182848) on March 22, 2019, following a traditional review. It is manufactured by Medtech S.A. in Montpellier, France.

Other devices from Medtech S.A

See all devices from Medtech S.A →

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ROSA ONE Spine application used for?

    The ROSA ONE Spine application is a stereotaxic instrument designed to assist in spinal procedures by providing precise guidance and positioning during surgery, based on its classification under product code OLO and its FDA 510(k) clearance as a Class II device.

  • Who manufactures the ROSA ONE Spine application and where is it made?

    The ROSA ONE Spine application is manufactured by Medtech S.A, with production located at Zac Eureka - 900 Rue Du Mas De Verchant, Montpellier, France, as specified in the device authorization data.

  • What regulatory pathway was used for the ROSA ONE Spine application?

    The ROSA ONE Spine application received FDA 510(k) clearance through a traditional review process, as indicated by the clearance_type field and the K-number K182848, with a decision date of March 22, 2019.