510(k) K203110
- Device
- iFuse Implant System - iFuse Navigation
- Applicant
- SI-BONE, Inc.
- 510(k) number
- K203110
- Product code
- OLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-11-09
- Date received
- 2020-10-15
- Regulation
- 882.4560
- Classification name
- Orthopedic Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Nancy Kaiser
- Address
- 471 El Camino Real Suite 101 Santa Clara CA US 95050 95050
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
Other 510(k) Records For Product Code OLO
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|---|---|---|---|
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| K260601 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | 2026-03-26 |
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| K260546 | Q Pedicle Instruments | K2m, Inc. | 2026-03-17 |
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| K260222 | Mako Total Knee Application | Mako Surgical Corp. | 2026-02-25 |
| K252989 | POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set | Point Robotics MedTech, Inc. | 2026-02-20 |
| K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | 2026-02-19 |