K130830 is an FDA 510(k) clearance for the INTEGRA LAMINOPLASTY SYSTEM. This device is classified as a Orthosis, Spine, Plate, Laminoplasty, Metal (Class II - Special Controls, product code NQW).
Submitted by Seaspine, Inc. (Vista, US). The FDA issued a Cleared decision on May 9, 2013, 44 days after receiving the submission on March 26, 2013.
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 | K130830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2013 |
| Decision Date | May 09, 2013 |
| Days to Decision | 44 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. |