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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2023-08-18 under 510(k) 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. The listed applicant is Stryker GmbH. The 510(k) number is K231257.

When did Pangea Utility Plating System, Pangea Platform receive FDA 510(k) clearance?

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

Who is the listed applicant for Pangea Utility Plating System, Pangea Platform?

The FDA 510(k) record lists Stryker GmbH as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Stryker GmbH as applicant

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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