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 |