The following data is part of a premarket notification filed by Depuy Spine,inc with the FDA for Merlin Spine System.
| Device ID | K033901 |
| 510k Number | K033901 |
| Device Name: | MERLIN SPINE SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | DEPUY SPINE,INC 325 PARAMONT DRIVE Raynham, MA 02780 |
| Contact | Jennifer Mooney |
| Correspondent | Jennifer Mooney DEPUY SPINE,INC 325 PARAMONT DRIVE Raynham, MA 02780 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-17 |
| Decision Date | 2004-03-31 |
| Summary: | summary |