AOS Anterolateral Proximal Humeral Plate
FDA 510(k) K160409 · Advanced Orthopaedic Solutions, Inc.
510(k) numberK160409
Submission
- Device name
- AOS Anterolateral Proximal Humeral Plate
- Applicant
- Advanced Orthopaedic Solutions, Inc.
Torrance, CA, US - Received
- February 16, 2016
- Decision date
- March 15, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTW – Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KTW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182285 | PK High Tibial Osteotomy Correction SystemKTW · Traditional | Paonan Biotech Co., Ltd. | 06/20/2019SE |
| K171606 | AOS Anterolateral Proximal Humeral PlateKTW · Special | Advanced Orthopaedic Solutions, Inc. (Aos) | 06/22/2017SE |
| K170693 | Phantom Small Bone Intramedullary Nail SystemKTW · Traditional | Paragon 28, Inc. | 06/19/2017SE |
| K122541 | Orthofix Contours Proimal Humeral Plate (PHP)KTW · Special | Orthofix Srl | 09/20/2012SE |
| K080590 | Aos Proximal Humeral PlateKTW · Traditional | Advanced Orthopaedic Solutions, Inc. | 05/06/2008SE |
| K080109 | Synthes (USA) Modular Blade Plate SystemKTW · Traditional | Synthes (Usa) | 03/20/2008SE |
| K062920 | Orthofix Titanium Humeral Plating System LSPKTW · Traditional | Orthofix Srl | 11/13/2006SE |
| K023360 | Leforte System Bone PlateKTW · Traditional | Jeil Medical Corporation | 10/25/2002SE |
| K012645 | Reprocessed Ebi External Fixation DevicesKTW · Traditional | Alliance Medical Corp. | 06/24/2002SE |
| K012634 | Reprocessed External Fixation DeviceKTW · Traditional | Alliance Medical, Inc. | 06/24/2002SE |
More from Alliance Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K202489 | AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating SystemHRS · Traditional | 10/26/2020SE |
| K202099 | AOS Galileo Trochanteric Nail SystemHSB · Special | 08/28/2020SE |
| K191598 | AOS ES Retrograde Femoral NailHSB · Special | 07/18/2019SE |
| K182466 | AOS Calcaneal Plating SystemHRS · Traditional | 10/30/2018SE |
| K143204 | AOS Clavicle Intramedullary DeviceHSB · Traditional | 06/03/2015SE |
| K141912 | Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…KTT · Traditional | 10/29/2014SE |
| K141228 | Aos 6.5MM Captured, Fully Threaded Cancellous ScrewHSB · Traditional | 07/08/2014SE |
| K133081 | Trochanteric Nails and Es Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…HSB · Special | 12/31/2013SE |
| K132005 | Retrograde Femoral NailHSB · Traditional | 09/10/2013SE |
| K123569 | Antegrade Femoral NailHSB · Traditional | 05/24/2013SE |
Questions and answers
When was AOS Anterolateral Proximal Humeral Plate cleared by the FDA?
AOS Anterolateral Proximal Humeral Plate (K160409) received a 510(k) decision of Substantially Equivalent on March 15, 2016, 28 days after the submission was received.
What is the product code of K160409?
The FDA product code is KTW – Appliance, Fixation, Nail/Blade/Plate Combination, Single Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.