The following data is part of a premarket notification filed by Lanx, Llc with the FDA for Lanx Spinal Fixation System.
| Device ID | K071877 |
| 510k Number | K071877 |
| Device Name: | LANX SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | LANX, LLC 1835 MARKET STREET, 28TH FLOOR Philadelphia, PA 19102 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan LANX, LLC 1835 MARKET STREET, 28TH FLOOR Philadelphia, PA 19102 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-09 |
| Decision Date | 2007-09-17 |
| Summary: | summary |