The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc with the FDA for Aos Anterolateral Proximal Humeral Plate.
| Device ID | K160409 |
| 510k Number | K160409 |
| Device Name: | AOS Anterolateral Proximal Humeral Plate |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC 3203 KASHIWA STREET Torrance, CA 90505 |
| Contact | Kazu Miyahara |
| Correspondent | Kazu Miyahara ADVANCED ORTHOPAEDIC SOLUTIONS, INC 3203 KASHIWA STREET Torrance, CA 90505 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-16 |
| Decision Date | 2016-03-15 |
| Summary: | summary |