The following data is part of a premarket notification filed by Lanx, Inc. with the FDA for Lanx Facet Screw System.
| Device ID | K101364 |
| 510k Number | K101364 |
| Device Name: | LANX FACET SCREW SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | LANX, INC. 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
| Contact | Michael Funk |
| Correspondent | Michael Funk LANX, INC. 390 INTERLOCKEN CRESCENT SUITE 890 Broomfield, CO 80021 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-14 |
| Decision Date | 2010-08-16 |
| Summary: | summary |