The following data is part of a premarket notification filed by Lanx, Inc with the FDA for Lanx Cervical Sa.
| Device ID | K112388 |
| 510k Number | K112388 |
| Device Name: | LANX CERVICAL SA |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | LANx, Inc 310 INTERLOCKEN PARKWAY, SUITE 120 Broomfield, CO 80021 |
| Contact | Michael Funk |
| Correspondent | Michael Funk LANx, Inc 310 INTERLOCKEN PARKWAY, SUITE 120 Broomfield, CO 80021 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-18 |
| Decision Date | 2011-12-16 |
| Summary: | summary |