The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Theken Vu Mesh Vbr System.
| Device ID | K070381 |
| 510k Number | K070381 |
| Device Name: | THEKEN VU MESH VBR SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | THEKEN SPINE LLC 283 E WATERLOO RD. Akron, OH 44319 |
| Contact | Dale Davison |
| Correspondent | Dale Davison THEKEN SPINE LLC 283 E WATERLOO RD. Akron, OH 44319 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-08 |
| Decision Date | 2007-04-25 |
| Summary: | summary |