The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes 6.0 Cocr And Cpt Ti-3 Rods.
| Device ID | K103287 |
| 510k Number | K103287 |
| Device Name: | SYNTHES 6.0 COCR AND CPT TI-3 RODS |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Elizabeth Kierzek |
| Correspondent | Elizabeth Kierzek SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| 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 | 2010-11-01 |
| Decision Date | 2011-01-05 |
| Summary: | summary |