K110963 is an FDA 510(k) clearance for the ELLIPSE OCCIPITO-CERVICO-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 May 5, 2011, 29 days after receiving the submission on April 6, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K110963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2011 |
| Decision Date | May 05, 2011 |
| Days to Decision | 29 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 |