The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos Tibial Nail.
Device ID | K070444 |
510k Number | K070444 |
Device Name: | AOS TIBIAL NAIL |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 2444 205TH STREET, UNIT 5 Torrance, CA 90501 |
Contact | Paul Doner |
Correspondent | Paul Doner ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 2444 205TH STREET, UNIT 5 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 | 2007-02-15 |
Decision Date | 2007-06-14 |
Summary: | summary |