The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos Tibial Nail.
| Device ID | K070444 |
| 510k Number | K070444 |
| Device Name: | AOS TIBIAL NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 2444 205TH STREET, UNIT 5 Torrance, CA 90501 |
| Contact | Paul Doner |
| Correspondent | Paul Doner ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 2444 205TH STREET, UNIT 5 Torrance, CA 90501 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-15 |
| Decision Date | 2007-06-14 |
| Summary: | summary |