The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Plymouth Thoracolumbar Plate System.
| Device ID | K120092 |
| 510k Number | K120092 |
| Device Name: | PLYMOUTH THORACOLUMBAR PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Sarah M Fitzgerald |
| Correspondent | Sarah M Fitzgerald GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-11 |
| Decision Date | 2012-04-13 |
| Summary: | summary |