K112561 is an FDA 510(k) clearance for the NUVASIVE COROENT NO-PROFILE 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 March 13, 2012, 193 days after receiving the submission on September 2, 2011.
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 | K112561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2011 |
| Decision Date | March 13, 2012 |
| Days to Decision | 193 days |
| Submission Type | Special |
| 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. |