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FDA 510(k)

Y3 Proximal Femoral Plate System

K-Number: K163003 · 2017-03-16

ApplicantPega Medical, Inc.
Decision Date2017-03-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Y3 Proximal Femoral Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Pega Medical, Inc.. It received FDA 510(k) clearance on 2017-03-16 under 510(k) number K163003. 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 Y3 Proximal Femoral Plate System?

Y3 Proximal Femoral Plate System is a medical device that received FDA 510(k) clearance on 2017-03-16. The listed applicant is Pega Medical, Inc.. The 510(k) number is K163003.

When did Y3 Proximal Femoral Plate System receive FDA 510(k) clearance?

Y3 Proximal Femoral Plate System received FDA 510(k) clearance on 2017-03-16, under 510(k) number K163003.

Who is the listed applicant for Y3 Proximal Femoral Plate System?

The FDA 510(k) record lists Pega Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Y3 Proximal Femoral Plate System?

The FDA product code for Y3 Proximal Femoral Plate System is HRS.

Other records listing Pega Medical, Inc. as applicant

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.

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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

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

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