The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Biospine Vbr System.
| Device ID | K110864 |
| 510k Number | K110864 |
| Device Name: | BIOSPINE VBR SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa Boyle |
| Correspondent | Lisa Boyle AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-29 |
| Decision Date | 2011-06-15 |
| Summary: | summary |