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510(k) K171606

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

K171606 is an FDA 510(k) premarket notification submitted by Advanced Orthopaedic Solutions, Inc. (Aos) for the device "AOS Anterolateral Proximal Humeral Plate". The FDA issued a decision of Substantially Equivalent on June 22, 2017. 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. (Aos) has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2017
Date Received
June 1, 2017
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. (Aos)

  • K181035 — AOS Small Fragment Plating System Lite (August 24, 2018)
  • K163014 — AOS Small Bone Nailing System (January 24, 2017)
  • K161913 — AOS Small Fragment Plating System (November 4, 2016)

Other clearances for product code KTW

  • K182285 — PK High Tibial Osteotomy Correction System (June 20, 2019)
  • K170693 — Phantom Small Bone Intramedullary Nail System (June 19, 2017)
  • K160409 — AOS Anterolateral Proximal Humeral Plate (March 15, 2016)
  • 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