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ROSA Spine

by Medtech S.A

510(k) K151511

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK151511 Date4 Jan 2016ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0639-2018 FDA Class II initiated 1 May 2017

    Robot arm being sent to the wrong position

    • Terminated Z-1755-2017 FDA Class II initiated 27 Feb 2017

    Unapproved change made by the supplier.

    • Terminated Z-0177-2018 FDA Class II initiated 29 Oct 2015

    A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.

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  • Withdrawn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

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