The following data is part of a premarket notification filed by Sanacor with the FDA for Alpine Pedicle Screw System.
| Device ID | K090477 |
| 510k Number | K090477 |
| Device Name: | ALPINE PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SANACOR PO BOX 1196 Pleasant Grove, UT 84062 |
| Contact | Michael Ensign |
| Correspondent | Michael Ensign SANACOR PO BOX 1196 Pleasant Grove, UT 84062 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-24 |
| Decision Date | 2009-07-27 |
| Summary: | summary |