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510(k) K250879

Paradigm System by Proprio, Inc. — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2025
Date Received
March 24, 2025
Clearance Type
Traditional
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.

Other clearances by Proprio, Inc.

  • K252950 — Paradigm System (December 15, 2025)
  • K243258 — Paradigm System (February 21, 2025)
  • K222291 — Paradigm System (April 21, 2023)

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