FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Genesys Spine Sacroiliac Joint Fusion System
K Number: K191748
·
Decision Sep 26, 2019
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
130
Applicant Total
31
Review Days
87
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Genesys Spine Sacroiliac Joint Fusion System
- K Number
- K191748
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genesys Spine
- Date Received
- July 1, 2019
- Decision Date
- September 26, 2019
- Product Code
- OUR
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OUR), ordered by most recent decision date.
CATAMARAN SI Joint Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
iFuse INTRA Ti Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
Falco Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Sacroiliac Joint Truss System (SJTS)
FDA 510(k)
FDA Class 2
·Orthopedic
OptumSI Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
SIros-X System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Genesys Spine
| K Number | Device Name | ||
|---|---|---|---|
| K252322 | SIros-X System | Oct 22, 2025 | Substantially Equivalent |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | Feb 7, 2025 | Substantially Equivalent |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System with Navigation | Mar 29, 2024 | Substantially Equivalent |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | Dec 13, 2023 | Substantially Equivalent |
| K220096 | Genesys Spine 3DP Lumbar Interbody System | Mar 9, 2022 | Substantially Equivalent |
| K191489 | Genesys Spine 3DP Cervical Interbody System | Jan 8, 2020 | Substantially Equivalent |
| K182987 | Genesys Spine 3DP Lumbar Interbody System | Dec 12, 2019 | Substantially Equivalent |
| K192678 | Genesys Spine Binary® Lumbar Plate System | Oct 24, 2019 | Substantially Equivalent |
| K192076 | Binary® Anterior Cervical Plate System | Aug 29, 2019 | Substantially Equivalent |
| K181295 | Genesys Spine AIS-C Cervical Stand-Alone System | Aug 29, 2018 | Substantially Equivalent |