restor3d TIDAL Lumbar Interbody Fusion System— 510(k) K234087

Clearance details

Applicant

Restor3D

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2023-12-22

Decision date

2024-01-22

Decision

Substantially Equivalent

Clearance type

Special

Location

Durham, NC, US

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• K252454 — Kinos Total Ankle System2025-09-03
• K243643 — restor3d Reverse Total Shoulder Arthroplasty System2025-05-19
• K242868 — Kinos Total Ankle System2024-10-18

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →