The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon.
Device ID | K141912 |
510k Number | K141912 |
Device Name: | AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
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 | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-15 |
Decision Date | 2014-10-29 |
Summary: | summary |