K113802 is an FDA 510(k) clearance for the ESCALATE LAMINOPLASTY SYSTEM. This device is classified as a Orthosis, Spine, Plate, Laminoplasty, Metal (Class II - Special Controls, product code NQW).
Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on April 16, 2012, 115 days after receiving the submission on December 23, 2011.
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 | K113802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2011 |
| Decision Date | April 16, 2012 |
| Days to Decision | 115 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. |