The following data is part of a premarket notification filed by Lanx, Inc. with the FDA for Lanx Fusion System.
| Device ID | K131547 |
| 510k Number | K131547 |
| Device Name: | LANX FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | LANX, INC. 310 INTERLOCKEN PARKWAY SUITE 120 Broomfield, CO 80021 |
| Contact | Alan Burkholder |
| Correspondent | Alan Burkholder LANX, INC. 310 INTERLOCKEN PARKWAY SUITE 120 Broomfield, CO 80021 |
| Product Code | OVD |
| Subsequent Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-29 |
| Decision Date | 2013-07-12 |
| Summary: | summary |