510(k) K250879
- Device
- Paradigm System
- Applicant
- Proprio, Inc.
- 510(k) number
- K250879
- Product code
- OLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-04
- Date received
- 2025-03-24
- 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
- Shannon Eubanks
- Address
- 111 W. John St., Suite 308 Seattle WA US 98119 98119
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 |
|---|---|---|---|
| 00850042604342 | Paradigm Navigated Drill Guide Case Assembly | Proprio, Inc. | 2025-06-09 |
| 00850042604335 | Paradigm Navigated Drill Guide Set | Proprio, Inc. | 2025-06-09 |
| 00850042604328 | Paradigm Depth Cannula, 5mm | Proprio, Inc. | 2025-06-09 |
| 00850042604311 | Paradigm Drill Guide Trocar | Proprio, Inc. | 2025-06-09 |
| 00850042604304 | Paradigm Depth Cannula, 2mm | Proprio, Inc. | 2025-06-09 |
| 00850042604298 | Paradigm Drill Bit, 3.0 mm | Proprio, Inc. | 2025-06-09 |
| 00850042604281 | Paradigm Drill Bit, 2.1 mm | Proprio, Inc. | 2025-06-09 |
| 00850042604274 | Paradigm Navigated Drill Guide | Proprio, Inc. | 2025-06-09 |
| 00850042604243 | Paradigm Navigated Drill Guide Case Lid | Proprio, Inc. | 2025-06-09 |
| 00850042604236 | Paradigm Navigated Drill Guide Case Tray | Proprio, Inc. | 2025-06-09 |
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| K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | 2026-02-19 |