510(k) K161210
- Device
- RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments For Use With The IPC(TM) Powerease(TM) System, And Medtronic Navigated Manual Reusable Instruments For Use With The StealthStation(TM) And IPC(TM) Powerease(TM) Systems
- Applicant
- Medtronic Sofamor Danek
- 510(k) number
- K161210
- Product code
- OUR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-08-12
- Date received
- 2016-04-28
- 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
- Ankit K. Shah
- Address
- 1800 Pyramid Pl. Memphis TN US 38132 38132
FDA Registration Numbers#
- 3012711663
- 3004142400
- 3008812560
- 2027062
- 3011127597
- 3005706667
- 3005497913
- 3008868758
- 1828464
- 9611281
- 3010863450
- 3007922509
- 3010143171
- 3016084569
- 1221763
- 1423662
- 3009189869
- 3006982954
- 1450662
- 3006082533
- 1935627
- 3010326971
- 3017597868
- 2134285
- 3036756245
- 3008455034
- 3008583793
- 3005819474
- 3009504230
- 1824199
- 3016002322
- 3025603301
- 3025141
- 3013413393
- 3022295665
- 3003525643
- 3009888740
- 3011500362
- 3000203391
- 2032093
- 3010120135
- 2032098
- 3018094310
- 3010560653
- 3008285983
- 3016443334
- 3008514120
- 1649518
- 3024124172
- 3014273501
- 2183449
- 3011656326
- 3012103114
- 3030400539
- 3031680559
- 3012495575
- 3014967969
- 1526439
- 2134947
- 3006017180
- 1222773
- 3009790163
- 1835251
- 1060840
- 3016438694
- 1220477
- 3009129735
- 1420032
- 3006783837
- 3043543260
- 3006846753
- 3014919610
- 3014170143
- 2647346
- 3003120897
- 3023189283
- 3005031160
- 3009959868
- 3042226236
- 3015941638
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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