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510(k) K201189

Stealthstation S8 Spine Software v1.3.0 by Medtronic Navigation, Inc. — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2020
Date Received
May 1, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

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  • K211269 — Visualase MRI-Guided Laser Ablation System (SW 3.4) (January 7, 2022)
  • K212397 — StealthStation S8 Cranial v2.0 (December 22, 2021)

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