The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Antegrade Femoral Nail.
Device ID | K123569 |
510k Number | K123569 |
Device Name: | ANTEGRADE FEMORAL NAIL |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 BEECH AVENUE UNIT B6 Torrance, CA 90501 |
Contact | Julie Glendrange |
Correspondent | Julie Glendrange ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 BEECH AVENUE UNIT B6 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 | 2012-11-20 |
Decision Date | 2013-05-24 |
Summary: | summary |