The following data is part of a premarket notification filed by Lanx, Llc with the FDA for Lanx Spinal Fixation System.
| Device ID | K043484 |
| 510k Number | K043484 |
| Device Name: | LANX SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| 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 | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-17 |
| Decision Date | 2005-05-16 |
| Summary: | summary |