The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Ellipse Occipito-cerico-thoracic Spinal System And Capitol Implants.
| Device ID | K123783 |
| 510k Number | K123783 |
| Device Name: | ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Contact | Sarah M Fitzgerald |
| Correspondent | Sarah M Fitzgerald GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095142464 | K123783 | 000 |
| 00889095733471 | K123783 | 000 |
| 00889095733488 | K123783 | 000 |
| 00889095733495 | K123783 | 000 |
| 00889095733501 | K123783 | 000 |
| 00889095733518 | K123783 | 000 |
| 00889095733525 | K123783 | 000 |
| 00889095733532 | K123783 | 000 |
| 00889095733549 | K123783 | 000 |
| 00889095733556 | K123783 | 000 |
| 00889095733563 | K123783 | 000 |
| 00889095852158 | K123783 | 000 |
| 00889095852165 | K123783 | 000 |
| 00889095852172 | K123783 | 000 |
| 00889095852189 | K123783 | 000 |
| 00889095852196 | K123783 | 000 |
| 00889095852202 | K123783 | 000 |
| 00889095852219 | K123783 | 000 |
| 00889095733464 | K123783 | 000 |