The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos Es Retrograde Femoral Nail.
| Device ID | K191598 |
| 510k Number | K191598 |
| Device Name: | AOS ES Retrograde Femoral Nail |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Advanced Orthopaedic Solutions, Inc. 3203 Kashiwa Street Torrance, CA 90505 |
| Contact | Elaine Nguyen |
| Correspondent | Elaine Nguyen Advanced Orthopaedic Solutions, Inc. 3203 Kashiwa Street Torrance, CA 90505 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-17 |
| Decision Date | 2019-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848665034776 | K191598 | 000 |
| 00848665034547 | K191598 | 000 |
| 00848665034530 | K191598 | 000 |
| 00848665034523 | K191598 | 000 |
| 00848665034516 | K191598 | 000 |
| 00848665034509 | K191598 | 000 |
| 00848665034448 | K191598 | 000 |
| 00848665034431 | K191598 | 000 |
| 00848665034424 | K191598 | 000 |
| 00848665034417 | K191598 | 000 |
| 00848665034400 | K191598 | 000 |
| 00848665034554 | K191598 | 000 |
| 00848665034615 | K191598 | 000 |
| 00848665034769 | K191598 | 000 |
| 00848665034752 | K191598 | 000 |
| 00848665034745 | K191598 | 000 |
| 00848665034738 | K191598 | 000 |
| 00848665034721 | K191598 | 000 |
| 00848665034660 | K191598 | 000 |
| 00848665034653 | K191598 | 000 |
| 00848665034646 | K191598 | 000 |
| 00848665034639 | K191598 | 000 |
| 00848665034622 | K191598 | 000 |
| 00848665034394 | K191598 | 000 |