The following data is part of a premarket notification filed by Lanx, Inc. with the FDA for Lanx Posterior Cervicothoracic Spinal Fixation System (pcfs).
| Device ID | K113434 |
| 510k Number | K113434 |
| Device Name: | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | LANX, INC. 210 INTERLOCKEN PARKWAY SUITE 120 Broomfield, CO 80021 |
| Contact | Michael Funk |
| Correspondent | Michael Funk LANX, INC. 210 INTERLOCKEN PARKWAY SUITE 120 Broomfield, CO 80021 |
| Product Code | NKB |
| 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 | 2011-11-21 |
| Decision Date | 2011-12-19 |
| Summary: | summary |