FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Osteotomy Truss System (OTS)
K Number: K220463
·
Decision May 18, 2022
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
11
Review Days
90
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Basic Information
- Device Name
- Osteotomy Truss System (OTS)
- K Number
- K220463
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 4Web Medical, Inc.
- Date Received
- February 17, 2022
- Decision Date
- May 18, 2022
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by 4Web Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | Dec 11, 2025 | Substantially Equivalent |
| 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 |
| K231739 | Cervical Spine Truss System (CSTS) | Sep 25, 2023 | Substantially Equivalent |
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | Feb 2, 2023 | 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 |
| 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 |