The following data is part of a premarket notification filed by Lanx, Llc with the FDA for Lanx Intervertebral Body Fusion Device.
| Device ID | K073144 |
| 510k Number | K073144 |
| Device Name: | LANX INTERVERTEBRAL BODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | LANX, LLC 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
| Contact | Greg Causey |
| Correspondent | Greg Causey LANX, LLC 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-07 |
| Decision Date | 2008-01-24 |
| Summary: | summary |