Home / 510(k) Clearances / K200511

510(k) K200511

ROSA ONE Brain application by Medtech S.A — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2020
Date Received
March 2, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

Other clearances by Medtech S.A

  • K231103 — ROSA ONE Brain Application (July 20, 2023)
  • K214065 — ROSA ONE Brain application (May 4, 2022)
  • K192173 — ROSA ONE Spine application (October 29, 2019)
  • K182848 — ROSA ONE Spine application (March 22, 2019)
  • K182417 — ROSA ONE Brain Application (February 7, 2019)
  • K172444 — ROSA BRAIN (v3.0.0.5) (March 28, 2018)
  • K151511 — ROSA Spine (January 4, 2016)
  • K151359 — ROSA Brain (December 18, 2015)
  • K101791 — ROSA SURGICAL DEVICE (September 23, 2010)
  • K092239 — ROSA SURGICAL DEVICE, MODEL ROSA 1.1 (November 17, 2009)

Other clearances for product code HAW

  • K231897 — NeuroAlign software (October 21, 2025)
  • K251317 — SOLOPASS 2.0 System (September 5, 2025)
  • K250893 — Ball Joint Guide Array (66295) (September 4, 2025)
  • K250505 — EZ-FIDUCIALS (July 9, 2025)
  • K242575 — Stereotaxic Guiding Surgical Devices, NaoTrac S (May 23, 2025)
  • K241327 — Navient Image Guide Navigation System (955-NC-NC), Cranial (February 5, 2025)
  • K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignm (January 28, 2025)
  • K243657 — ClearPoint System (Software Version 3.0) (January 24, 2025)
  • K241333 — Geniant Cranial (Navigated Neurosurgical Positioning Robot) (January 17, 2025)
  • K242480 — FLASH EVD System (10-0002) (December 27, 2024)