The following data is part of a premarket notification filed by Lanx, Inc. with the FDA for Lanx Spinal Fixation System.
| Device ID | K083581 |
| 510k Number | K083581 |
| Device Name: | LANX SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | LANX, INC. 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
| Contact | Andrew Lamborne |
| Correspondent | Andrew Lamborne LANX, INC. 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-04 |
| Decision Date | 2009-04-07 |
| Summary: | summary |