iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System — Restor3D, Inc. (510(k) K243768)
iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System — Restor3D, Inc. (510(k) K243768) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System; Applicant: Restor3D, Inc.; Clearance track: 510(k).
| Device name | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System |
|---|---|
| Applicant | Restor3D, Inc. |
| Clearance track | 510(k) |
| Submission number | K243768 |
| Decision | Substantially Equivalent |
| Decision date | 2025-03-27 |
| Date received | 2024-12-06 |
| Product code | MBH |
| Device class | 2 |
| Medical specialty | Orthopedic |
| Applicant location | NC, US |
| Source | openFDA device |
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$1999/mo
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