510(k) K162364

Intellijoint HIP Generation 2A System by Intellijoint Surgical, Inc. — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 2, 2017
Date Received: August 23, 2016
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 Intellijoint Surgical, Inc.

K211876 — Intellijoint VIEW (November 12, 2021)
K191507 — Intellijoint® Navigation System (October 1, 2019)
K172849 — Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint (November 16, 2017)
K171525 — Intellijoint HIP Generation 2B System (October 30, 2017)
K151364 — Intellijoint HIP(tm) System (December 28, 2015)
K133759 — INTELLIJOINT HIP (July 23, 2014)

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