FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device
K Number: K200002
·
Decision May 29, 2020
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
13
Review Days
148
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Basic Information
- Device Name
- Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device
- K Number
- K200002
- 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
- January 2, 2020
- Decision Date
- May 29, 2020
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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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 |
| K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | Aug 12, 2019 | 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 |