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510(k) K160409

AOS Anterolateral Proximal Humeral Plate by Advanced Orthopaedic Solutions, Inc. — Product Code KTW

K160409 is an FDA 510(k) premarket notification submitted by Advanced Orthopaedic Solutions, Inc. for the device "AOS Anterolateral Proximal Humeral Plate". The FDA issued a decision of Substantially Equivalent on March 15, 2016. The device falls under product code KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component), a Class II device regulated under 21 CFR 888.3030. Advanced Orthopaedic Solutions, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2016
Date Received
February 16, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Advanced Orthopaedic Solutions, Inc.

  • K202489 — AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System (October 26, 2020)
  • K202099 — AOS Galileo™ Trochanteric Nail System (August 28, 2020)
  • K191598 — AOS ES Retrograde Femoral Nail (July 18, 2019)
  • K182466 — AOS Calcaneal Plating System (October 30, 2018)
  • 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)

Other clearances for product code KTW

  • K182285 — PK High Tibial Osteotomy Correction System (June 20, 2019)
  • K171606 — AOS Anterolateral Proximal Humeral Plate (June 22, 2017)
  • K170693 — Phantom Small Bone Intramedullary Nail System (June 19, 2017)
  • K122541 — ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) (September 20, 2012)
  • K080590 — AOS PROXIMAL HUMERAL PLATE (May 6, 2008)
  • K080109 — SYNTHES (USA) MODULAR BLADE PLATE SYSTEM (March 20, 2008)
  • K062920 — ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP (November 13, 2006)
  • K023360 — LEFORTE SYSTEM BONE PLATE (October 25, 2002)
  • K012645 — REPROCESSED EBI EXTERNAL FIXATION DEVICES (June 24, 2002)
  • K012634 — REPROCESSED EXTERNAL FIXATION DEVICE (June 24, 2002)

FDA data resources