Cleared Special

REDUCT? Headless Compression Screw System

K201662 · Skeletal Dynamics, Inc. · Orthopedic
Jul 2020
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K201662 is an FDA 510(k) clearance for the REDUCT? Headless Compression Screw 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 July 16, 2020, 27 days after receiving the submission on June 19, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K201662 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2020
Decision Date July 16, 2020
Days to Decision 27 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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