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510(k) K202099

AOS Galileo Trochanteric Nail System by Advanced Orthopaedic Solutions, Inc. — Product Code HSB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 28, 2020
Date Received: July 29, 2020
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Rod, Fixation, Intramedullary And Accessories
Device Class: Class II
Regulation Number: 888.3020
Review Panel: OR
Submission Type

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K160409 — AOS Anterolateral Proximal Humeral Plate (March 15, 2016)
K143204 — AOS Clavicle Intramedullary Device (June 3, 2015)
K141912 — AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FI (October 29, 2014)
K141228 — AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW (July 8, 2014)
K133081 — TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEG (December 31, 2013)
K132005 — RETROGRADE FEMORAL NAIL (September 10, 2013)
K123569 — ANTEGRADE FEMORAL NAIL (May 24, 2013)

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