The following data is part of a premarket notification filed by Lanx, Inc. with the FDA for Spinal Fixation System.
| Device ID | K092536 |
| 510k Number | K092536 |
| Device Name: | SPINAL FIXATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | LANX, INC. 1835 MARKET ST. SUITE 2820 Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan LANX, INC. 1835 MARKET ST. SUITE 2820 Philadelphia, PA 19103 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-19 |
| Decision Date | 2009-10-30 |
| Summary: | summary |