The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos Solid Locking Lag Screw, Aos Telescoping Lag Screw.
Device ID | K120148 |
510k Number | K120148 |
Device Name: | AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 Beech Ave. Unit B6 Torrance, CA 90501 |
Contact | Julie Glendrange |
Correspondent | Julie Glendrange ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 Beech Ave. 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 | 2012-01-18 |
Decision Date | 2012-10-02 |
Summary: | summary |