FDA 510(k)

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.

K-Number: K153716 · 2016-05-17

Decision Date2016-05-17

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. is the device name listed in this FDA 510(k) record. The listed applicant is Gpc Medical, Ltd.. It received FDA 510(k) clearance on 2016-05-17 under 510(k) number K153716. 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 GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.?

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Gpc Medical, Ltd.. The 510(k) number is K153716.

When did GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. receive FDA 510(k) clearance?

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. received FDA 510(k) clearance on 2016-05-17, under 510(k) number K153716.

Who is the listed applicant for GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.?

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

What is the FDA product code for GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.?

The FDA product code for GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. is HRS.

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Other records listing Gpc Medical, Ltd. as applicant

K203811GPC Intraheal Intramedullary Nailing System K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System

Related Devices (Code: HRS)

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip Technics K261406Versalock 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 Technics K261054RibPlate 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.