The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. (aos) with the FDA for Aos Small Fragment Plating System Lite.
| Device ID | K181035 |
| 510k Number | K181035 |
| Device Name: | AOS Small Fragment Plating System Lite |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-18 |
| Decision Date | 2018-08-24 |