The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos Galileo™ Trochanteric Nail System.
| Device ID | K202099 |
| 510k Number | K202099 |
| Device Name: | AOS Galileo™ Trochanteric Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Advanced Orthopaedic Solutions, Inc. 3203 Kashiwa Street Torrance, CA 90505 |
| Contact | Jolie Krance |
| Correspondent | Jolie Krance 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 | 2020-07-29 |
| Decision Date | 2020-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848665038194 | K202099 | 000 |
| 00848665036527 | K202099 | 000 |
| 00848665036510 | K202099 | 000 |
| 00848665036480 | K202099 | 000 |
| 00848665036473 | K202099 | 000 |
| 00848665036244 | K202099 | 000 |
| 00848665036169 | K202099 | 000 |
| 00848665036152 | K202099 | 000 |
| 00848665036145 | K202099 | 000 |
| 00848665036138 | K202099 | 000 |
| 00848665036121 | K202099 | 000 |
| 00848665036114 | K202099 | 000 |
| 00848665036107 | K202099 | 000 |
| 00848665036091 | K202099 | 000 |
| 00848665036084 | K202099 | 000 |
| 00848665036077 | K202099 | 000 |
| 00848665031522 | K202099 | 000 |
| 00848665039177 | K202099 | 000 |
| 00848665036534 | K202099 | 000 |
| 00848665036541 | K202099 | 000 |
| 00848665036558 | K202099 | 000 |
| 00848665038170 | K202099 | 000 |
| 00848665037814 | K202099 | 000 |
| 00848665036763 | K202099 | 000 |
| 00848665036756 | K202099 | 000 |
| 00848665036749 | K202099 | 000 |
| 00848665036732 | K202099 | 000 |
| 00848665036725 | K202099 | 000 |
| 00848665036718 | K202099 | 000 |
| 00848665036701 | K202099 | 000 |
| 00848665036695 | K202099 | 000 |
| 00848665036688 | K202099 | 000 |
| 00848665036671 | K202099 | 000 |
| 00848665036602 | K202099 | 000 |
| 00848665036596 | K202099 | 000 |
| 00848665036589 | K202099 | 000 |
| 00848665036572 | K202099 | 000 |
| 00848665036565 | K202099 | 000 |
| 00848665039160 | K202099 | 000 |