The following data is part of a premarket notification filed by Zimmer Spine, Inc. with the FDA for Silhouette Spinal Fixation System.
| Device ID | K042702 |
| 510k Number | K042702 |
| Device Name: | SILHOUETTE SPINAL FIXATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
| Contact | Tim Crabtree |
| Correspondent | Tim Crabtree ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-30 |
| Decision Date | 2004-11-23 |
| Summary: | summary |