Cleared Traditional

Protean Fragment Plating System

K241815 · Skeletal Dynamics, Inc. · Orthopedic
Sep 2024
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K241815 is an FDA 510(k) clearance for the Protean Fragment Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Skeletal Dynamics, Inc. (Miami, US). The FDA issued a Cleared decision on September 26, 2024, 94 days after receiving the submission on June 24, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K241815 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2024
Decision Date September 26, 2024
Days to Decision 94 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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