The following data is part of a premarket notification filed by Aesculap Implant System, Inc. with the FDA for Ais Odontoid Fracture Fixation System.
| Device ID | K142707 |
| 510k Number | K142707 |
| Device Name: | AIS Odontoid Fracture Fixation System |
| Classification | Screw, Fixation, Bone |
| Applicant | AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-22 |
| Decision Date | 2014-12-19 |
| Summary: | summary |