FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
K Number: K223362
·
Decision Feb 2, 2023
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
150
Applicant Total
9
Review Days
91
Basic Information
- Device Name
- Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
- K Number
- K223362
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 4WEB Medical, Inc.
- Date Received
- November 3, 2022
- Decision Date
- February 2, 2023
- 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 |
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Other Clearances by 4WEB Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240388 | Osteotomy Truss System (OTS) | Nov 1, 2024 | Substantially Equivalent |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | Apr 22, 2024 | Substantially Equivalent |
| K230088 | Ankle Truss System (ATS) | Mar 21, 2024 | Substantially Equivalent |
| K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion Device | Jan 5, 2023 | Substantially Equivalent |
| K221283 | Hammertoe Truss System (HTS) | Sep 6, 2022 | Substantially Equivalent |
| K220463 | Osteotomy Truss System (OTS) | May 18, 2022 | Substantially Equivalent |
| K212527 | Cervical Spine Truss System Plating Solution (CSTS-PS) | May 17, 2022 | Substantially Equivalent |
| K211388 | Lateral Spine Truss System (LSTS) Interbody Fusion Device | Aug 5, 2021 | Substantially Equivalent |