510(k) K181881
- Device
- Outlet Sacroiliac Joint Fusion System
- Applicant
- SIJ Surgical
- 510(k) number
- K181881
- Product code
- OUR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-10-03
- Date received
- 2018-07-13
- 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
- Daniel Hoehn
- Address
- 6829 Falls Of Neuse Rd., Suite 103 Raleigh NC US 27615 27615
FDA Registration Numbers#
- 1833920
- 1222773
- 3015941638
- 3005061536
- 1030489
- 3025141
- 3016112537
- 3004188066
- 3010047402
- 3014967969
- 3009129735
- 3012495575
- 1528646
- 3009417901
- 3008868758
- 3012429289
- 3009973336
- 3006982954
- 3010143171
- 3003525643
- 1649518
- 3016084569
- 3031680559
- 2134285
- 9681465
- 3006082533
- 2027062
- 3042226236
- 3009790163
- 1529009
- 2133928
- 3031024716
- 3005977257
- 3009380063
- 3019837678
- 2531195
- 3006172536
- 3022295665
- 3008285983
- 3011127597
- 3009189869
- 1835251
- 3008526708
- 1423662
- 3024124172
- 3043543260
- 3000203391
- 3014273501
- 2032098
- 3010047454
- 3010560653
- 1060840
- 3010531060
- 3008455034
- 3010197224
- 3005641619
- 1530390
- 3005031160
- 3010120326
- 3030400539
- 3012711663
- 2027467
- 2530808
- 3009973505
- 3023852420
- 8043792
- 3015399803
- 3004499989
- 1526711
- 1221763
- 3010326971
- 3005819474
- 3003477135
- 3016261131
- 1058584
- 1057425
- 1824199
- 3025603301
- 1424263
- 3009959868
Source Documents#
Other 510(k) Records For Product Code OUR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K251365 | OptumSI Implant System | Si Solutions, LLC | 2025-11-20 |
| 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 |
| K251075 | DYNAMIS™ Implant System | Promethean Restorative, LLC | 2025-04-25 |
Legacy Summary#
summary
FDA Review#
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