The following data is part of a premarket notification filed by Us Spine with the FDA for Modification To Preference Pedicle Screw System.
| Device ID | K081883 |
| 510k Number | K081883 |
| Device Name: | MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | US SPINE 13540 GUILD AVE Apple Valley, MN 55124 |
| Contact | Richard Jansen |
| Correspondent | Richard Jansen US SPINE 13540 GUILD AVE Apple Valley, MN 55124 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-02 |
| Decision Date | 2008-09-24 |
| Summary: | summary |