The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Anthem Fracture System.
| Device ID | K180554 |
| 510k Number | K180554 |
| Device Name: | ANTHEM Fracture System |
| Classification | Plate, Fixation, Bone |
| Applicant | Globus Medical Inc. 2560 General Armistead Avenue Valley Forge Business Center Audubon, PA 19403 |
| Contact | Kelly J. Baker |
| Correspondent | Kelly J. Baker Globus Medical Inc. 2560 General Armistead Avenue Valley Forge Business Center Audubon, PA 19403 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-01 |
| Decision Date | 2018-10-22 |
| Summary: | summary |