K080664 is an FDA 510(k) clearance for the RELIEVE LAMINOPLASTY FIXATION SYSTEM. This device is classified as a Orthosis, Spine, Plate, Laminoplasty, Metal (Class II - Special Controls, product code NQW).
Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on July 25, 2008, 137 days after receiving the submission on March 10, 2008.
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 | K080664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2008 |
| Decision Date | July 25, 2008 |
| Days to Decision | 137 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. |