Cleared Traditional

Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System

K242445 · Stryker GmbH · Orthopedic
Oct 2024
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K242445 is an FDA 510(k) clearance for the Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Stryker GmbH (Selzach, Solothurn, Ch, CH). The FDA issued a Cleared decision on October 6, 2024, 51 days after receiving the submission on August 16, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K242445 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2024
Decision Date October 06, 2024
Days to Decision 51 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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