The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos Clavicle Intramedullary Device.
| Device ID | K143204 |
| 510k Number | K143204 |
| Device Name: | AOS Clavicle Intramedullary Device |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 3203 KASHIWA STREET Torrance, CA 90505 |
| Contact | Anna Hwang |
| Correspondent | Anna Hwang ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 3203 KASHIWA STREET 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 | 2014-11-07 |
| Decision Date | 2015-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848665023800 | K143204 | 000 |
| 00848665021196 | K143204 | 000 |
| 00848665021202 | K143204 | 000 |
| 00848665021219 | K143204 | 000 |
| 00848665021226 | K143204 | 000 |
| 00848665021233 | K143204 | 000 |
| 00848665021240 | K143204 | 000 |
| 00848665021257 | K143204 | 000 |
| 00848665021264 | K143204 | 000 |
| 00848665021271 | K143204 | 000 |
| 00848665023763 | K143204 | 000 |
| 00848665023770 | K143204 | 000 |
| 00848665023787 | K143204 | 000 |
| 00848665023794 | K143204 | 000 |
| 00848665021189 | K143204 | 000 |