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 | K100191 |
| 510k Number | K100191 |
| Device Name: | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-22 |
| Decision Date | 2010-04-15 |
| Summary: | summary |