510(k) K250599
- Device
- ExcelsiusGPS? Instruments
- Applicant
- Globus Medical, Inc.
- 510(k) number
- K250599
- Product code
- OLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-05
- Date received
- 2025-02-28
- Regulation
- 882.4560
- Classification name
- Orthopedic Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Jennifer Antonacci
- Address
- Valley Forge Business Center 2560 General Armistead Ave. Audubon CA US 19403 19403
FDA Registration Numbers
- 3014273424
- 1221485
- 3009962553
- 3006563559
- 3007515069
- 3009266751
- 3017823294
- 3014498598
- 3013194153
- 3013404959
- 9610622
- 3003637761
- 3010287737
- 3027305794
- 3006776201
- 3033536255
- 3008110533
- 3010047454
- 3009049161
- 1047843
- 1421101
- 1043653
- 3013682146
- 3009185973
- 3007344102
- 3008868758
- 1644408
- 1928237
- 3014725904
- 3010097171
- 3003617485
- 3020983478
- 2031966
- 3010120148
- 3004024955
- 1220477
- 3009888740
- 3003761012
- 3008583793
- 3010047402
- 3017528621
- 3016261131
- 3009417901
- 3006654680
- 3013485140
- 3015831087
- 3012120772
- 3007700286
- 2135156
- 3010822102
- 3013422236
- 3015967359
- 3007521480
- 9616696
- 3005751028
- 1935627
- 1828464
- 3010232390
- 3004513872
- 1834331
- 1030489
- 1424263
- 3019807891
- 3015941638
- 3009051471
- 3004727093
- 8031020
- 9611390
- 3030412764
- 1833920
- 3012764194
- 3004464325
- 3004209178
- 3012131184
- 3010057495
- 3018405359
- 3001239363
- 3007441485
- 3010120135
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00193982637248 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637132 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637149 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637156 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637163 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637170 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637187 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637194 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637200 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637217 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637224 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637231 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637378 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637255 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637262 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637279 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637286 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637293 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637309 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637316 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637323 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637330 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
| 00193982637347 | EXCELSIUSGPS | GLOBUS MEDICAL, INC. | 2026-01-27 |
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