The following data is part of a premarket notification filed by Spinal Usa with the FDA for Pss System.
| Device ID | K071438 |
| 510k Number | K071438 |
| Device Name: | PSS SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINAL USA 644 LAKELAND EAST DR., STE. A Flowood, MS 39232 |
| Contact | Jeffrey Johnson |
| Correspondent | Jeffrey Johnson SPINAL USA 644 LAKELAND EAST DR., STE. A Flowood, MS 39232 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-23 |
| Decision Date | 2007-08-21 |
| Summary: | summary |