K100043 is an FDA 510(k) clearance for the COROENT XLR STANDALONE SYSTEM. This device is classified as a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II - Special Controls, product code OVD).
Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on June 16, 2010, 159 days after receiving the submission on January 8, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation..
| 510(k) Number | K100043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2010 |
| Decision Date | June 16, 2010 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation. |