Cleared Special

Hand Trauma Threaded Nail System

K230908 · Skeletal Dynamics, Inc. · Orthopedic
Apr 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K230908 is an FDA 510(k) clearance for the Hand Trauma Threaded Nail System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Skeletal Dynamics, Inc. (Miami, US). The FDA issued a Cleared decision on April 28, 2023, 28 days after receiving the submission on March 31, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K230908 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2023
Decision Date April 28, 2023
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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