The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Ellipse Occipito-cervico-thoracic Spinal System.
| Device ID | K110963 |
| 510k Number | K110963 |
| Device Name: | ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Kelly J Baker, Ph.d |
| Correspondent | Kelly J Baker, Ph.d GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-06 |
| Decision Date | 2011-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849044036404 | K110963 | 000 |
| 00849044036268 | K110963 | 000 |
| 00849044036275 | K110963 | 000 |
| 00849044036282 | K110963 | 000 |
| 00849044036299 | K110963 | 000 |
| 00849044036305 | K110963 | 000 |
| 00849044036312 | K110963 | 000 |
| 00849044036329 | K110963 | 000 |
| 00849044036336 | K110963 | 000 |
| 00849044036343 | K110963 | 000 |
| 00849044036350 | K110963 | 000 |
| 00849044036367 | K110963 | 000 |
| 00849044036374 | K110963 | 000 |
| 00849044036381 | K110963 | 000 |
| 00849044036398 | K110963 | 000 |
| 00849044036251 | K110963 | 000 |