The following data is part of a premarket notification filed by Lanx, Llc with the FDA for Lanx Vbr System.
| Device ID | K052384 |
| 510k Number | K052384 |
| Device Name: | LANX VBR SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | LANX, LLC 200 GREGORY LANE SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf LANX, LLC 200 GREGORY LANE SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-30 |
| Decision Date | 2005-10-07 |
| Summary: | summary |