Cleared Traditional

ExtremiLOCK Lateral Ankle Fusion Plates

K203479 · Osteomed · Orthopedic
Feb 2021
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K203479 is an FDA 510(k) clearance for the ExtremiLOCK Lateral Ankle Fusion Plates, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on February 24, 2021, 89 days after receiving the submission on November 27, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K203479 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2020
Decision Date February 24, 2021
Days to Decision 89 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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