The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Ellipse Occipito-cerico-thoracic Spinal System.
| Device ID | K090565 |
| 510k Number | K090565 |
| Device Name: | ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Kelly J Baker |
| Correspondent | Kelly J Baker 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 | 2009-03-02 |
| Decision Date | 2009-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849044035490 | K090565 | 000 |
| 00849044035483 | K090565 | 000 |
| 00849044035476 | K090565 | 000 |
| 00849044035469 | K090565 | 000 |
| 00849044035452 | K090565 | 000 |
| 00849044035445 | K090565 | 000 |
| 00849044035438 | K090565 | 000 |