510(k) clearances

TIDAL Fusion Cage System

Restor3D, Inc. · Orthopedic

K242356Substantially EquivalentTraditionalSAI
Open FDA's page for this record
Third party flag
N
City
Durham
Advisory committee description
Orthopedic
Address 1
4001 Nc-54 Hwy.
Address 2
Suite 3160
Statement or summary
Summary
Product code
SAI
Zip code
27709
Applicant
Restor3D, Inc.
Decision date
2025-03-24
Decision code
SESE
Country code
US
Device name
TIDAL Fusion Cage System
Advisory committee
OR
Contact
Brianna Prindle
K number
K242356
State
NC
Date received
2024-08-08
Review advisory committee
OR
Postal code
27709
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Ankle Fusion Cage
Medical specialty description
Orthopedic
Regulation number
888.3020
Device class
2
Registration number
3011127597, 3014833750, 3009189869, 3010370500, 3048515471, 3029890418
FEI number
3011127597, 3014833750, 3009189869, 3010370500, 3048515471, 3029890418
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.