FDA 510(k) Applications Submitted by Jennifer Antonacci
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200047 |
01/09/2020 |
ExcelsiusGPS Cranial 1.0 Module |
Globus Medical Inc. |
| K240568 |
02/29/2024 |
DuraProÖ Oscillating System |
Globus Medical, Inc. |
| K230565 |
03/01/2023 |
HILINEÖ Fixation System |
Globus Medical Inc. |
| K220659 |
03/07/2022 |
AUTOBAHN(R) EVO Femoral Nails |
Globus Medical Inc. |
| K240669 |
03/11/2024 |
ACTIFYÖ 3D Total Knee System, ACTIFYÖ Total Knee System |
Globus Medical, Inc |
| K240721 |
03/18/2024 |
ExcelsiusFlexÖ |
Globus Medical, Inc |
| K240947 |
04/08/2024 |
TENSOR« Suture Button System |
Globus Medical, Inc |
| K201087 |
04/23/2020 |
CORBEL Spacers |
Globus Medical, Inc. |
| K241260 |
05/06/2024 |
ACTIFYÖ Unicondylar Knee System |
Globus Medical, Inc |
| K231333 |
05/08/2023 |
STRETTOÖ Cable System |
Globus Medical Inc. |
| K241525 |
05/30/2024 |
ExcelsiusXRÖ |
Globus Medical, Inc. |
| K221737 |
06/15/2022 |
InstaFill Graft Delivery System, SIGNIFY Bioactive |
Globus Medical Inc. |
| K231850 |
06/23/2023 |
QUARTEX« Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS« Instruments |
Globus Medical Inc |
| K211957 |
06/24/2021 |
QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments |
Globus Medical Inc. |
| K201733 |
06/25/2020 |
Provident II Hip Stems |
Globus Medical Inc. |
| K232318 |
08/03/2023 |
VICTORYÖ Lumbar Plate System |
Globus Medical, Inc |
| K212433 |
08/04/2021 |
Anthem Fracture System |
Globus Medical Inc. |
| K222409 |
08/10/2022 |
CAPTIVATE« Compression Screws |
Globus Medical, Inc. |
| K202496 |
08/31/2020 |
ANTHEM Fracture System |
Globus Medical Inc. |
| K203153 |
10/22/2020 |
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS |
Globus Medical Inc. |
| K243456 |
11/07/2024 |
ONVOYÖ Acetabular System |
Globus Medical, Inc |
| K213591 |
11/12/2021 |
ANTHEM« Fracture System |
Globus Medical Inc. |
| K233638 |
11/13/2023 |
VERZAÖ High Speed Drills |
Globus Medical, Inc. |
| K233735 |
11/22/2023 |
ADIRAÖ Lateral Plate System |
Globus Medical Inc |
| K243671 |
11/27/2024 |
ExcelsiusGPS« Instruments |
Globus Medical, Inc. |
| K213842 |
12/09/2021 |
ONVOY Acetabular System |
Globus Medical Inc. |
| K234035 |
12/20/2023 |
COSINEÖ Spacer |
Globus Medical, Inc. |
|
|