K171434 is an FDA 510(k) clearance for the ROCCIA® MultiLIF. This device is classified as a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II - Special Controls, product code MAX).
Submitted by Silony Medical GmbH (Leinfelden-Echterdingen, DE). The FDA issued a Cleared decision on December 21, 2017, 220 days after receiving the submission on May 15, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..
| 510(k) Number | K171434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2017 |
| Decision Date | December 21, 2017 |
| Days to Decision | 220 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MAX - Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft. |