The following data is part of a premarket notification filed by Us Spine with the FDA for Us Spine Facet Fixation System.
| Device ID | K061041 |
| 510k Number | K061041 |
| Device Name: | US SPINE FACET FIXATION SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| 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 | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-14 |
| Decision Date | 2006-06-19 |
| Summary: | summary |