The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions with the FDA for Aos Calcaneal Plating System.
| Device ID | K182466 |
| 510k Number | K182466 |
| Device Name: | AOS Calcaneal Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Advanced Orthopaedic Solutions 3203 Kashiwa Street Torrance, CA 90505 |
| Contact | Elaine Nguyen |
| Correspondent | Elaine Nguyen Advanced Orthopaedic Solutions 3203 Kashiwa Street Torrance, CA 90505 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-10 |
| Decision Date | 2018-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848665037067 | K182466 | 000 |
| 00848665032031 | K182466 | 000 |
| 00848665031805 | K182466 | 000 |
| 00848665032895 | K182466 | 000 |
| 00848665037654 | K182466 | 000 |
| 00848665037487 | K182466 | 000 |
| 00848665037463 | K182466 | 000 |
| 00848665036848 | K182466 | 000 |
| 00848665036831 | K182466 | 000 |
| 00848665036190 | K182466 | 000 |
| 00848665036183 | K182466 | 000 |
| 00848665034066 | K182466 | 000 |
| 00848665032758 | K182466 | 000 |
| 00848665032741 | K182466 | 000 |
| 00848665032734 | K182466 | 000 |
| 00848665032727 | K182466 | 000 |
| 00848665032710 | K182466 | 000 |
| 00848665032949 | K182466 | 000 |
| 00848665032956 | K182466 | 000 |
| 00848665032963 | K182466 | 000 |
| 00848665037050 | K182466 | 000 |
| 00848665037043 | K182466 | 000 |
| 00848665037036 | K182466 | 000 |
| 00848665037029 | K182466 | 000 |
| 00848665037012 | K182466 | 000 |
| 00848665037159 | K182466 | 000 |
| 00848665037142 | K182466 | 000 |
| 00848665037128 | K182466 | 000 |
| 00848665037111 | K182466 | 000 |
| 00848665037104 | K182466 | 000 |
| 00848665037081 | K182466 | 000 |
| 00848665037074 | K182466 | 000 |
| 00848665036947 | K182466 | 000 |
| 00848665032994 | K182466 | 000 |
| 00848665032987 | K182466 | 000 |
| 00848665032970 | K182466 | 000 |
| 00848665032703 | K182466 | 000 |