K051296 is an FDA 510(k) clearance for the SIJF CANNULATED SCREW SYSTEM. This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on August 26, 2005, 100 days after receiving the submission on May 18, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K051296 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2005 |
| Decision Date | August 26, 2005 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OUR - Sacroiliac Joint Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |
| Definition | Sacroiliac Joint Fusion |