The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Sijf Cannulated Screw System.
| Device ID | K051296 |
| 510k Number | K051296 |
| Device Name: | SIJF CANNULATED SCREW SYSTEM |
| Classification | Sacroiliac Joint Fixation |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DRIVE Raynham, MA 02780 |
| Contact | Sharon Starowicz |
| Correspondent | Sharon Starowicz DEPUY SPINE, INC. 325 PARAMOUNT DRIVE Raynham, MA 02780 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-18 |
| Decision Date | 2005-08-26 |
| Summary: | summary |