Cleared Traditional

Pangea Utility Plating System, Pangea Platform

K231257 · Stryker GmbH · Orthopedic
Aug 2023
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K231257 is an FDA 510(k) clearance for the Pangea Utility Plating System, Pangea Platform, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Stryker GmbH (Malwah, US). The FDA issued a Cleared decision on August 18, 2023, 109 days after receiving the submission on May 1, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K231257 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2023
Decision Date August 18, 2023
Days to Decision 109 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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