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FDA 510(k)

Park's Pectus System

K-Number: K191057 · 2020-03-19

ApplicantTdm Co., Ltd.
Decision Date2020-03-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Park's Pectus System is the device name listed in this FDA 510(k) record. The listed applicant is Tdm Co., Ltd.. It received FDA 510(k) clearance on 2020-03-19 under 510(k) number K191057. 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 Park's Pectus System?

Park's Pectus System is a medical device that received FDA 510(k) clearance on 2020-03-19. The listed applicant is Tdm Co., Ltd.. The 510(k) number is K191057.

When did Park's Pectus System receive FDA 510(k) clearance?

Park's Pectus System received FDA 510(k) clearance on 2020-03-19, under 510(k) number K191057.

Who is the listed applicant for Park's Pectus System?

The FDA 510(k) record lists Tdm Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Park's Pectus System?

The FDA product code for Park's Pectus System is HRS.

Other records listing Tdm Co., Ltd. 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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