510(k) K242356
K242356 is an FDA 510(k) premarket notification submitted by Restor3D, Inc. for the device "TIDAL Fusion Cage System". The FDA issued a decision of Substantially Equivalent on March 24, 2025. The device falls under product code SAI (Ankle Fusion Cage), a Class II device regulated under 21 CFR 888.3020. Restor3D, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2025
- Date Received
- August 8, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ankle Fusion Cage
- Device Class
- Class II
- Regulation Number
- 888.3020
- Review Panel
- OR
- Submission Type
Intended for use as an accessory to a tibiotalocalcaneal Intramedullary (IM) rod as part of a fusion construct for failed ankle arthrodesis or failed ankle arthroplasty. Not intended for standalone use.