restor3d Inc.
FDA Regulatory Profile
restor3d Inc. appears in FDA public data with 3 recalls, 19 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1026-2022, Class II) was initiated on March 30, 2022. Its most recent 510(k) clearance was granted on July 1, 2026.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 19
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1026-2022 | Class II | Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit | March 30, 2022 |
| Z-1027-2022 | Class II | Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual | March 30, 2022 |
| Z-1028-2022 | Class II | Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic ma | March 30, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260556 | Veritas Shoulder System | July 1, 2026 |
| K253992 | Veritas Reverse Total Shoulder System | May 7, 2026 |
| K252067 | Velora Acetabular System | December 5, 2025 |
| K252454 | Kinos Total Ankle System | September 3, 2025 |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty System | May 19, 2025 |
| K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System | March 27, 2025 |
| K242356 | TIDAL Fusion Cage System | March 24, 2025 |
| K242868 | Kinos Total Ankle System | October 18, 2024 |
| K241482 | Kinos Total Ankle System | July 22, 2024 |
| K240591 | restor3d Kinos Axiom Total Ankle System | April 29, 2024 |
| K234087 | restor3d TIDAL Lumbar Interbody Fusion System | January 22, 2024 |
| K232595 | Kinos Axiom Total Ankle System | November 28, 2023 |
| K231458 | Extremity Staple | August 3, 2023 |
| K223326 | Axiom PSR System | March 30, 2023 |
| K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | June 17, 2022 |
| K201393 | restor3d MTP Implant | May 25, 2022 |
| K211789 | restor3d Pin Implants | January 4, 2022 |
| K201314 | Restor3d Utility Wedge | June 17, 2021 |
| K193491 | restor3d Metallic Interference Screw | March 19, 2020 |