The following data is part of a premarket notification filed by Aesculap Implants Systems, Inc. with the FDA for Modulift Vertebral Body Replacement (vbr) System.
| Device ID | K172032 |
| 510k Number | K172032 |
| Device Name: | Modulift Vertebral Body Replacement (VBR) System |
| Classification | Spinal Vertebral Body Replacement Device - Cervical |
| Applicant | Aesculap Implants Systems, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa Boyle |
| Correspondent | Lisa M. Boyle Aesculap Implants Systems, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | PLR |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-05 |
| Decision Date | 2017-11-20 |
| Summary: | summary |