Cleared Traditional

restor3d MTP Implant

K201393 · Restor3D, Inc. · Orthopedic
May 2022
Decision
728d
Days
Class 2
Risk

About This 510(k) Submission

K201393 is an FDA 510(k) clearance for the restor3d MTP Implant, a Prosthesis, Toe, Hemi-, Phalangeal (Class II — Special Controls, product code KWD), submitted by Restor3D, Inc. (Durham, US). The FDA issued a Cleared decision on May 25, 2022, 728 days after receiving the submission on May 27, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3730.

Submission Details

510(k) Number K201393 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2020
Decision Date May 25, 2022
Days to Decision 728 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWD — Prosthesis, Toe, Hemi-, Phalangeal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3730

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