K181717 is an FDA 510(k) clearance for the Life Spine Laminoplasty System. This device is classified as a Orthosis, Spine, Plate, Laminoplasty, Metal (Class II - Special Controls, product code NQW).
Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on October 12, 2018, 106 days after receiving the submission on June 28, 2018.
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 | K181717 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2018 |
| Decision Date | October 12, 2018 |
| Days to Decision | 106 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. |