The following data is part of a premarket notification filed by Co-ligne Ag with the FDA for Gii Spinal Fixation System, Gii-ti-poly Axial Screw.
| Device ID | K083567 |
| 510k Number | K083567 |
| Device Name: | GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | CO-LIGNE AG 1070 CONRAD AVENUE, SUITE 230 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf CO-LIGNE AG 1070 CONRAD AVENUE, SUITE 230 Concord, CA 94520 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-03 |
| Decision Date | 2009-09-14 |
| Summary: | summary |