The following data is part of a premarket notification filed by Aesculap Implant System, Inc. with the FDA for Ais Modulift Vbr System.
| Device ID | K133802 |
| 510k Number | K133802 |
| Device Name: | AIS MODULIFT VBR SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | AESCULAP IMPLANT SYSTEM, INC. 3773 CORPORATE PWKY. Center Valley, PA 18034 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle AESCULAP IMPLANT SYSTEM, INC. 3773 CORPORATE PWKY. 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 | 2013-12-13 |
| Decision Date | 2014-04-17 |
| Summary: | summary |