The following data is part of a premarket notification filed by Aesculap Implant Systems, Inc. with the FDA for Arcadiusxp C Spinal System.
| Device ID | K153629 |
| 510k Number | K153629 |
| Device Name: | ArcadiusXP C Spinal System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Aesculap Implant Systems, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle Aesculap Implant Systems, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-18 |
| Decision Date | 2016-05-25 |
| Summary: | summary |