The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. (aos) with the FDA for Aos Small Fragment Plating System.
| Device ID | K161913 |
| 510k Number | K161913 |
| Device Name: | AOS Small Fragment Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) 3203 KASHIWA STREET Torrance, CA 90505 |
| Contact | Alex Bhaskarla |
| Correspondent | Alex Bhaskarla ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) 3203 KASHIWA STREET Torrance, CA 90505 |
| Product Code | HRS |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-12 |
| Decision Date | 2016-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848665037265 | K161913 | 000 |
| 00848665030020 | K161913 | 000 |
| 00848665036954 | K161913 | 000 |
| 00848665036961 | K161913 | 000 |
| 00848665036978 | K161913 | 000 |
| 00848665036985 | K161913 | 000 |
| 00848665036992 | K161913 | 000 |
| 00848665037005 | K161913 | 000 |
| 00848665037166 | K161913 | 000 |
| 00848665037173 | K161913 | 000 |
| 00848665037180 | K161913 | 000 |
| 00848665037197 | K161913 | 000 |
| 00848665037210 | K161913 | 000 |
| 00848665037227 | K161913 | 000 |
| 00848665037234 | K161913 | 000 |
| 00848665037241 | K161913 | 000 |
| 00848665037258 | K161913 | 000 |
| 00848665030013 | K161913 | 000 |