510(k) K251365
- Device
- OptumSI Implant System
- Applicant
- Si Solutions, LLC
- 510(k) number
- K251365
- Product code
- OUR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-20
- Date received
- 2025-05-01
- Regulation
- 888.3040
- Classification name
- Sacroiliac Joint Fixation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Craig Meyer
- Address
- 1010 Club Village Dr. Suite C Columbia MO US 62503 62503
FDA Registration Numbers#
- 1935627
- 3010047454
- 3014938863
- 3014919610
- 2134947
- 3006172536
- 3004188066
- 3010047402
- 1420032
- 3008812560
- 1220477
- 1828464
- 3042226236
- 1043534
- 3005031160
- 1030489
- 3000203391
- 3005497913
- 3010120148
- 3010143171
- 3005180920
- 3009051471
- 3005706667
- 3010197224
- 3024999441
- 3016438694
- 3009504230
- 3015941638
- 1529009
- 3004499989
- 3008526708
- 3030400539
- 3009380063
- 3011656326
- 3005819474
- 3014170143
- 3007922509
- 3007344102
- 3009973336
- 3012711663
- 2032093
- 3013564228
- 8010468
- 3019837678
- 3010120135
- 1221763
- 1526439
- 3008110533
- 3031680559
- 3010863450
- 3007345964
- 3006846753
- 3004142400
- 3008868758
- 8031020
- 3019878714
- 3013912820
- 3014273501
- 9611281
- 3006128100
- 3008514120
- 3008583793
- 3016261131
- 2027062
- 2530808
- 3006783837
- 1057425
- 3034676720
- 3043543260
- 2531195
- 3007125392
- 3009790163
- 3011127597
- 3033509898
- 2134285
- 2133928
- 3016084569
- 1424263
- 3025603301
- 1824199
Source Documents#
Other 510(k) Records For Product Code OUR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262522 | Odys-SI Screw | Medyssey Co, Ltd. | 2026-10-15 |
| K261381 | TiLink-L™ SI Joint Fusion System | SurGenTec, LLC | 2026-08-24 |
| K260477 | CATAMARAN™ SI Joint Fusion System | Tenon Medical | 2026-04-08 |
| K253488 | iFuse INTRA Ti™ Implant System | SI-BONE, Inc. | 2026-02-11 |
| K253611 | Falco Fusion System | Mcnicoll Surgical, Inc. | 2026-01-29 |
| K252834 | Sacroiliac Joint Truss System (SJTS) | 4Web Medical | 2026-01-28 |
| K252322 | SIros-X System | Genesys Spine | 2025-10-22 |
| K253094 | iFuse Bedrock Granite Implant System | SI-BONE, Inc. | 2025-10-09 |
| K250894 | Eminent Spine Posterior SI System | Eminent Spine | 2025-10-07 |
| K250647 | SImmetry+ System | Sivantage | 2025-07-29 |
| K250247 | panaSIa SI Fusion System | Wenzel Spine, Inc. | 2025-07-09 |
| K251395 | The Rialto™ SI Fusion System | Medtronic Sofamor Danek USA, Inc. | 2025-06-26 |
| K242431 | Omnia Medical PsiF DNA™ System | Omnia Medical, LLC | 2025-06-06 |
| K251525 | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System | Si-Technology, LLC | 2025-06-06 |
| K250001 | Patriot SI Implant System | Spinal Simplicity, LLC | 2025-06-03 |