K090565 is an FDA 510(k) clearance for the ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on June 30, 2009, 120 days after receiving the submission on March 2, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K090565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2009 |
| Decision Date | June 30, 2009 |
| Days to Decision | 120 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWP — Appliance, Fixation, Spinal Interlaminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3050 |