The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Truss Thoracolumbar Plate System.
| Device ID | K092108 |
| 510k Number | K092108 |
| Device Name: | TRUSS THORACOLUMBAR PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Contact | Kelly J Baker |
| Correspondent | Kelly J Baker GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER 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 | 2009-07-14 |
| Decision Date | 2009-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849044084900 | K092108 | 000 |
| 00849044084764 | K092108 | 000 |
| 00849044084757 | K092108 | 000 |
| 00849044084740 | K092108 | 000 |
| 00849044084733 | K092108 | 000 |
| 00849044084726 | K092108 | 000 |
| 00849044084719 | K092108 | 000 |
| 00849044084702 | K092108 | 000 |
| 00849044084696 | K092108 | 000 |
| 00849044084689 | K092108 | 000 |
| 00849044084672 | K092108 | 000 |
| 00849044084771 | K092108 | 000 |
| 00849044084788 | K092108 | 000 |
| 00849044084795 | K092108 | 000 |
| 00849044084894 | K092108 | 000 |
| 00849044084887 | K092108 | 000 |
| 00849044084870 | K092108 | 000 |
| 00849044084863 | K092108 | 000 |
| 00849044084856 | K092108 | 000 |
| 00849044084849 | K092108 | 000 |
| 00849044084832 | K092108 | 000 |
| 00849044084825 | K092108 | 000 |
| 00849044084818 | K092108 | 000 |
| 00849044084801 | K092108 | 000 |
| 00849044084665 | K092108 | 000 |