The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos 6.5mm Captured, Fully Threaded Cancellous Screw.
| Device ID | K141228 |
| 510k Number | K141228 |
| Device Name: | AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 3203 KASHIWA STREET Torrance, CA 90505 |
| Contact | Anna Hwang |
| Correspondent | Anna Hwang ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 3203 KASHIWA STREET Torrance, CA 90505 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-12 |
| Decision Date | 2014-07-08 |
| Summary: | summary |