510(k) K242414
- Device
- TiLink-P Joint Fusion System
- Applicant
- SurGenTec, LLC
- 510(k) number
- K242414
- Product code
- OUR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-21
- Date received
- 2024-08-14
- 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
Related Records
Applicant Contact
- Contact
- Gui Pires
- Address
- 911 Clint Moore Rd. Boca Raton FL US 33487 33487
FDA Registration Numbers
- 3024124172
- 1000577893
- 3016002322
- 3014129047
- 2183449
- 3010197224
- 3013912820
- 3010665091
- 3010143171
- 3031024716
- 1423662
- 3000203391
- 3012249461
- 3033509898
- 3008110533
- 3014938863
- 3010047454
- 3012711663
- 1530390
- 3018094310
- 3009973505
- 3010863450
- 3008868758
- 3042226236
- 3011656326
- 3014725904
- 3022295665
- 3009790163
- 3009189869
- 3010560653
- 3012429289
- 1824199
- 8043792
- 3010120148
- 1057425
- 3014680795
- 1526439
- 2531195
- 3000170817
- 1220477
- 3005061536
- 1528646
- 3009888740
- 3003761012
- 3008812560
- 3008583793
- 3006783837
- 3016112537
- 3010047402
- 3025141
- 3005819474
- 3005180920
- 3006172536
- 3016261131
- 3005031160
- 8010468
- 1060840
- 3009417901
- 3011127597
- 3004188066
- 2647346
- 2032093
- 3012495575
- 3013564228
- 3009380063
- 1649518
- 2134947
- 3016438694
- 3023852420
- 3007700286
- 3008514120
- 3008285983
- 3008455034
- 1526534
- 3012103114
- 3013413393
- 3025603301
- 3019837678
- 1420032
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 |
| K251525 | SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System | Si-Technology, LLC | 2025-06-06 |
| K242431 | Omnia Medical PsiF DNA System | Omnia Medical, 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 |