The following data is part of a premarket notification filed by Innovative Spinal Technologies Inc with the FDA for Paramount Vbr System.
| Device ID | K062759 |
| 510k Number | K062759 |
| Device Name: | PARAMOUNT VBR SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | INNOVATIVE SPINAL TECHNOLOGIES INC 111FORBES BLVD Mansfield, MA 02048 |
| Contact | Gina Yeh |
| Correspondent | Gina Yeh INNOVATIVE SPINAL TECHNOLOGIES INC 111FORBES BLVD Mansfield, MA 02048 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-15 |
| Decision Date | 2007-01-12 |
| Summary: | summary |