FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Testa TP Pivoting Spacer System
K Number: K243816
·
Decision Jun 27, 2025
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
59
Review Days
197
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Basic Information
- Device Name
- Testa TP Pivoting Spacer System
- K Number
- K243816
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spine Wave, Inc.
- Date Received
- December 12, 2024
- Decision Date
- June 27, 2025
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K243514 | Salvo® Robotic Navigation Instruments | Apr 3, 2025 | Substantially Equivalent |
| K240685 | Salvo® Spine System | May 6, 2024 | Substantially Equivalent |
| K231275 | Exceed Biplanar Expandable Interbody System | Jul 25, 2023 | Substantially Equivalent |
| K222362 | Salvo® Spine System | Aug 29, 2022 | Substantially Equivalent |
| K202476 | Salvo® Spine System | Nov 5, 2020 | Substantially Equivalent |
| K192526 | Spine Wave Navigated Instruments | Oct 10, 2019 | Substantially Equivalent |
| K191045 | Salvo Spine System | Jul 10, 2019 | Substantially Equivalent |