The following data is part of a premarket notification filed by Rsb Spine Llc. with the FDA for Interplate Vbr System.
| Device ID | K070316 |
| 510k Number | K070316 |
| Device Name: | INTERPLATE VBR SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | RSB SPINE LLC. 8202 SHERMAN ROAD Chesterland, OH 44026 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden RSB SPINE LLC. 8202 SHERMAN ROAD Chesterland, OH 44026 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-01 |
| Decision Date | 2007-04-19 |
| Summary: | summary |