Cleared Traditional

restor3d Pin Implants

K211789 · Restor3d · Orthopedic
Jan 2022
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K211789 is an FDA 510(k) clearance for the restor3d Pin Implants, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Restor3d (Durham, US). The FDA issued a Cleared decision on January 4, 2022, 208 days after receiving the submission on June 10, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K211789 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2021
Decision Date January 04, 2022
Days to Decision 208 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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