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510(k) K191598

AOS ES Retrograde Femoral Nail by Advanced Orthopaedic Solutions, Inc. — Product Code HSB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 18, 2019
Date Received: June 17, 2019
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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K141912 — AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FI (October 29, 2014)
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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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