The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Expedium Spine System 5.5mm Commerically Pure Titanium Spinal Rods.
| Device ID | K052131 |
| 510k Number | K052131 |
| Device Name: | EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Liz Lavelle |
| Correspondent | Liz Lavelle DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-05 |
| Decision Date | 2005-09-28 |
| Summary: | summary |