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510(k) K172849

Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray by Intellijoint Surgical, Inc. — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2017
Date Received
September 20, 2017
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.

Other clearances by Intellijoint Surgical, Inc.

  • K211876 — Intellijoint VIEW (November 12, 2021)
  • K191507 — Intellijoint® Navigation System (October 1, 2019)
  • K171525 — Intellijoint HIP Generation 2B System (October 30, 2017)
  • K162364 — Intellijoint HIP Generation 2A System (March 2, 2017)
  • K151364 — Intellijoint HIP(tm) System (December 28, 2015)
  • K133759 — INTELLIJOINT HIP (July 23, 2014)

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