The following data is part of a premarket notification filed by Us Spine with the FDA for Ltd Polyaxial Fixation System.
| Device ID | K062785 |
| 510k Number | K062785 |
| Device Name: | LTD POLYAXIAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-18 |
| Decision Date | 2006-12-26 |
| Summary: | summary |