The following data is part of a premarket notification filed by Lanx, Inc. with the FDA for Lanx Cervical Intervertebral Body Fusion System.
| Device ID | K103660 |
| 510k Number | K103660 |
| Device Name: | LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | LANX, INC. 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
| Contact | William Sandul |
| Correspondent | William Sandul LANX, INC. 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-15 |
| Decision Date | 2011-02-28 |
| Summary: | summary |