The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. (aos) with the FDA for Aos Anterolateral Proximal Humeral Plate.
Device ID | K171606 |
510k Number | K171606 |
Device Name: | AOS Anterolateral Proximal Humeral Plate |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
Applicant | Advanced Orthopaedic Solutions, Inc. (AOS) 3203 Kashiwa Street Torrance, CA 90505 |
Contact | Alex Bhaskarla |
Correspondent | Alex Bhaskarla Advanced Orthopaedic Solutions, Inc. (AOS) 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 | 2017-06-01 |
Decision Date | 2017-06-22 |
Summary: | summary |