510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242356Substantially Equivalent

TIDAL Fusion Cage System

restor3d, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242356 is the FDA 510(k) clearance record for TIDAL Fusion Cage System, a class II device, cleared for Restor3D, Inc. on under FDA product code SAI (Ankle Fusion Cage). FDA's definition for product code SAI reads: "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". FDA records list 19 510(k) clearances for Restor3D, Inc., from to . As of , FDA records show no recalls naming K242356.

Clearance record

Decision date
Received
(228 days to decision)
Product code
SAI Ankle Fusion Cage
Regulation
21 CFR 888.3020
Device class
Class II
Review panel
Orthopedic
Applicant
Restor3D, Inc. 4001 Nc-54 Hwy., Durham NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SAI

Trailing 12 months

FDA records hold no clearances under product code SAI in the trailing twelve months.

FDA records show no clearances under product code SAI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SAI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260