The following data is part of a premarket notification filed by Co-ligne Ag with the FDA for Gii Spinal Fixation System.
| Device ID | K051089 |
| 510k Number | K051089 |
| Device Name: | GII SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | CO-LIGNE AG 200 GREGORY LANE, SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf CO-LIGNE AG 200 GREGORY LANE, SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-28 |
| Decision Date | 2005-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640173163695 | K051089 | 000 |
| 07640173163619 | K051089 | 000 |
| 07640173163626 | K051089 | 000 |
| 07640173163633 | K051089 | 000 |
| 07640173163640 | K051089 | 000 |
| 07640173163657 | K051089 | 000 |
| 07640173163664 | K051089 | 000 |
| 07640173163671 | K051089 | 000 |
| 07640173163688 | K051089 | 000 |
| 07640173163602 | K051089 | 000 |