K121276 is an FDA 510(k) clearance for the NEURO VENTION LAMINPLASTY PLATING SYSTEM. This device is classified as a Orthosis, Spine, Plate, Laminoplasty, Metal (Class II - Special Controls, product code NQW).
Submitted by Neurovention, LLC (Colorado Springs, US). The FDA issued a Cleared decision on August 29, 2012, 124 days after receiving the submission on April 27, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050. This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure..
| 510(k) Number | K121276 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2012 |
| Decision Date | August 29, 2012 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NQW - Orthosis, Spine, Plate, Laminoplasty, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3050 |
| Definition | This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure. |