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FDA 510(k)

Pangea Utility Plating System, Pangea Platform

K-Number: K231257 · 2023-08-18

ApplicantStryker GmbH
Decision Date2023-08-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pangea Utility Plating System, Pangea Platform is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2023-08-18 under approval number K231257. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pangea Utility Plating System, Pangea Platform?

Pangea Utility Plating System, Pangea Platform is a medical device that received FDA 510(k) clearance on 2023-08-18. It is manufactured by Stryker GmbH. The 510(k) number is K231257.

When was Pangea Utility Plating System, Pangea Platform approved by the FDA?

Pangea Utility Plating System, Pangea Platform received FDA 510(k) clearance on 2023-08-18, under approval number K231257.

What company makes Pangea Utility Plating System, Pangea Platform?

Pangea Utility Plating System, Pangea Platform is manufactured by Stryker GmbH.

What is the FDA product code for Pangea Utility Plating System, Pangea Platform?

The FDA product code for Pangea Utility Plating System, Pangea Platform is HRS.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

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Related Devices (Code: HRS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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