The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. (aos) with the FDA for Aos Small Bone Nailing System.
| Device ID | K163014 |
| 510k Number | K163014 |
| Device Name: | AOS Small Bone Nailing System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Advanced Orthopaedic Solutions, Inc. (AOS) 3203 Kashiwa St. Torrance, CA 90505 |
| Contact | Alex Bhaskarla |
| Correspondent | Alex Bhaskarla Advanced Orthopaedic Solutions, Inc. (AOS) 3203 Kashiwa St. Torrance, CA 90505 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-28 |
| Decision Date | 2017-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848665034219 | K163014 | 000 |
| 00848665028782 | K163014 | 000 |
| 00848665028850 | K163014 | 000 |
| 00848665028867 | K163014 | 000 |
| 00848665028874 | K163014 | 000 |
| 00848665028881 | K163014 | 000 |
| 00848665028935 | K163014 | 000 |
| 00848665028942 | K163014 | 000 |
| 00848665030051 | K163014 | 000 |
| 00848665032055 | K163014 | 000 |
| 00848665032116 | K163014 | 000 |
| 00848665034059 | K163014 | 000 |
| 00848665028119 | K163014 | 000 |