K150994 is an FDA 510(k) clearance for the NuVasive CoRoent Thoracolumbar Implants. This device is classified as a Intervertebral Fusion Device With Bone Graft, Thoracic (Class II - Special Controls, product code PHM).
Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on June 17, 2015, 63 days after receiving the submission on April 15, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Thoracic Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..
| 510(k) Number | K150994 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2015 |
| Decision Date | June 17, 2015 |
| Days to Decision | 63 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PHM — Intervertebral Fusion Device With Bone Graft, Thoracic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Thoracic Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft. |