The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Anthem Fracture System.
| Device ID | K212433 |
| 510k Number | K212433 |
| Device Name: | Anthem Fracture System |
| Classification | Plate, Fixation, Bone |
| Applicant | Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Contact | Jennifer Antonacci |
| Correspondent | Jennifer Antonacci Globus Medical Inc. 2560 General Armistead Ave. 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 | 2021-08-04 |
| Decision Date | 2021-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00193982355807 | K212433 | 000 |
| 00193982355616 | K212433 | 000 |
| 00193982355425 | K212433 | 000 |
| 00193982343996 | K212433 | 000 |
| 00193982343804 | K212433 | 000 |
| 00193982343613 | K212433 | 000 |