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510(k) K141912

AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON by Advanced Orthopaedic Solutions, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2014
Date Received
July 15, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K182466 — AOS Calcaneal Plating System (October 30, 2018)
  • K160409 — AOS Anterolateral Proximal Humeral Plate (March 15, 2016)
  • K143204 — AOS Clavicle Intramedullary Device (June 3, 2015)
  • 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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