The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos Modular Femoral Nail.
| Device ID | K012190 |
| 510k Number | K012190 |
| Device Name: | AOS MODULAR FEMORAL NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 333 WEST 6TH ST., SUITE 202 San Pedro, CA 90731 |
| Contact | Gary Sohngen |
| Correspondent | Gary Sohngen ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 333 WEST 6TH ST., SUITE 202 San Pedro, CA 90731 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-13 |
| Decision Date | 2001-09-24 |
| Summary: | summary |