The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos Cannulated Bone Screw System.
Device ID | K014185 |
510k Number | K014185 |
Device Name: | AOS CANNULATED BONE SCREW SYSTEM |
Classification | Screw, Fixation, Bone |
Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 333 WEST 6TH ST., SUITE 202 San Pedro, CA 90731 |
Contact | Paul Doner |
Correspondent | Paul Doner ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 333 WEST 6TH ST., SUITE 202 San Pedro, CA 90731 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-12-20 |
Decision Date | 2002-02-13 |
Summary: | summary |