The following data is part of a premarket notification filed by Lanx, Llc with the FDA for Lanx Spinal Fixation System.
| Device ID | K120399 |
| 510k Number | K120399 |
| Device Name: | LANX SPINAL FIXATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | LANX, LLC 310 INTERLOCKEN PARKWAY STE 120 Broomfield, CO 80021 |
| Contact | Michael Funk |
| Correspondent | Michael Funk LANX, LLC 310 INTERLOCKEN PARKWAY STE 120 Broomfield, CO 80021 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-08 |
| Decision Date | 2012-03-09 |
| Summary: | summary |