Cleared Traditional

Small Bone Nailing System

K211439 · Skeletal Dynamics, Inc. · Orthopedic
Sep 2021
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K211439 is an FDA 510(k) clearance for the Small Bone Nailing System, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Skeletal Dynamics, Inc. (Miami, US). The FDA issued a Cleared decision on September 30, 2021, 143 days after receiving the submission on May 10, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K211439 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2021
Decision Date September 30, 2021
Days to Decision 143 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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