510(k) K243768
iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System by
Restor3D, Inc.
— Product Code MBH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2025
- Date Received
- December 6, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3565
- Review Panel
- OR
- Submission Type