FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
restor3d TIDAL Lumbar Interbody Fusion System
K Number: K234087
·
Decision Jan 22, 2024
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
12
Review Days
31
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Basic Information
- Device Name
- restor3d TIDAL Lumbar Interbody Fusion System
- K Number
- K234087
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Restor3D
- Date Received
- December 22, 2023
- Decision Date
- January 22, 2024
- 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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Other Clearances by Restor3D
| K Number | Device Name | ||
|---|---|---|---|
| K253992 | Veritas Reverse Total Shoulder System | May 7, 2026 | Substantially Equivalent |
| K252454 | Kinos Total Ankle System | Sep 3, 2025 | Substantially Equivalent |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty System | May 19, 2025 | Substantially Equivalent |
| K242868 | Kinos Total Ankle System | Oct 18, 2024 | Substantially Equivalent |
| K241482 | Kinos Total Ankle System | Jul 22, 2024 | Substantially Equivalent |
| K232595 | Kinos Axiom Total Ankle System | Nov 28, 2023 | Substantially Equivalent |
| K231458 | Extremity Staple | Aug 3, 2023 | Substantially Equivalent |
| K223326 | Axiom PSR System | Mar 30, 2023 | Substantially Equivalent |
| K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | Jun 17, 2022 | Substantially Equivalent |
| K211789 | restor3d Pin Implants | Jan 4, 2022 | Substantially Equivalent |