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 |