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510(k) K214065

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2022
Date Received
December 27, 2021
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.S

  • K231103 — ROSA ONE Brain Application (July 20, 2023)
  • K200511 — ROSA ONE Brain application (May 29, 2020)
  • 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)

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