FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cervical Spinal Truss System-Stand Alone (CSTS-SA)
K Number: K190870
·
Decision Aug 12, 2019
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
13
Review Days
131
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
- Cervical Spinal Truss System-Stand Alone (CSTS-SA)
- K Number
- K190870
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 4Web, Inc.
- Date Received
- April 3, 2019
- Decision Date
- August 12, 2019
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OVE), ordered by most recent decision date.
CONDUIT ZERO-P VA Secured Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
NeckTune 3D SA Cervical Cage
FDA 510(k)
FDA Class 2
·Orthopedic
SABER-C System
FDA 510(k)
FDA Class 2
·Orthopedic
SAGI Cervical Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Uni-C Cervical Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
E3D-C Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by 4Web, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | Feb 12, 2026 | Substantially Equivalent |
| K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | Mar 10, 2021 | Substantially Equivalent |
| K200002 | Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device | May 29, 2020 | Substantially Equivalent |
| K190926 | Hammertoe Truss System (HTS) | Jul 23, 2019 | Substantially Equivalent |
| K172294 | Osteotomy Truss System (OTS) | Feb 22, 2018 | Substantially Equivalent |
| K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion Device | Jan 8, 2018 | Substantially Equivalent |
| K172392 | Lateral Spinal Truss System (LSTS) Interbody Fusion Device | Nov 7, 2017 | Substantially Equivalent |
| K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion Device | Sep 8, 2017 | Substantially Equivalent |
| K170851 | Anterior Spine Truss System (STS) Interbody Fusion Device | Aug 7, 2017 | Substantially Equivalent |
| K153436 | LATERAL Spine Truss System | Jun 6, 2016 | Substantially Equivalent |