The following data is part of a premarket notification filed by Sulzer Spine-tech with the FDA for Device Modification Of Silhouette Spindal Fixation System.
| Device ID | K012173 |
| 510k Number | K012173 |
| Device Name: | DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SULZER SPINE-TECH 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2027 |
| Contact | Kristyn M Benson |
| Correspondent | Kristyn M Benson SULZER SPINE-TECH 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2027 |
| Product Code | KWP |
| 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 | 2001-07-12 |
| Decision Date | 2001-09-28 |
| Summary: | summary |