The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos Proximal Humeral Nail.
| Device ID | K090478 |
| 510k Number | K090478 |
| Device Name: | AOS PROXIMAL HUMERAL NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 BEECH AVENUE UNIT B6 Torrance, CA 90501 |
| Contact | Paul Doner |
| Correspondent | Paul Doner ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 BEECH AVENUE UNIT B6 Torrance, CA 90501 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-24 |
| Decision Date | 2009-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848665017021 | K090478 | 000 |
| 00848665016857 | K090478 | 000 |
| 00848665016840 | K090478 | 000 |
| 00848665016833 | K090478 | 000 |
| 00848665016826 | K090478 | 000 |
| 00848665016819 | K090478 | 000 |
| 00848665007220 | K090478 | 000 |
| 00848665007213 | K090478 | 000 |
| 00848665007206 | K090478 | 000 |
| 00848665007190 | K090478 | 000 |
| 00848665005752 | K090478 | 000 |
| 00848665005745 | K090478 | 000 |
| 00848665005554 | K090478 | 000 |
| 00848665005547 | K090478 | 000 |
| 00848665013931 | K090478 | 000 |
| 00848665016864 | K090478 | 000 |
| 00848665016871 | K090478 | 000 |
| 00848665017014 | K090478 | 000 |
| 00848665017007 | K090478 | 000 |
| 00848665016994 | K090478 | 000 |
| 00848665016987 | K090478 | 000 |
| 00848665016970 | K090478 | 000 |
| 00848665016963 | K090478 | 000 |
| 00848665016956 | K090478 | 000 |
| 00848665016949 | K090478 | 000 |
| 00848665016932 | K090478 | 000 |
| 00848665016925 | K090478 | 000 |
| 00848665016918 | K090478 | 000 |
| 00848665016901 | K090478 | 000 |
| 00848665016895 | K090478 | 000 |
| 00848665016888 | K090478 | 000 |
| 00848665000658 | K090478 | 000 |