The following data is part of a premarket notification filed by Lanx, Llc with the FDA for Modification To Lanx Spinal Fixation System.
| Device ID | K093285 |
| 510k Number | K093285 |
| Device Name: | MODIFICATION TO LANX SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | LANX, LLC 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
| Contact | Andrew Lamborne |
| Correspondent | Andrew Lamborne LANX, LLC 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-20 |
| Decision Date | 2009-12-10 |
| Summary: | summary |