510(k) K173372

ExactechGPS Total Shoulder Application by Blue Ortho — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 24, 2017
Date Received: October 27, 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 Blue Ortho

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K213546 — ExactechGPS Total Shoulder Application, Equinoxe Planning Software (January 6, 2022)
K193618 — ExactechGPS System (September 2, 2020)
K162567 — ExactechGPS Total Shoulder Application, Equinoxe Planning Software (April 5, 2017)
K152764 — EXACTECH GPS (July 13, 2016)
K100742 — EXACTECH GPS (October 21, 2010)

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