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FDA 510(k)

DRPx Locking Distal Radius Plate System

K-Number: K212601 · 2022-04-05

ApplicantOrthopaedic Implant Company
Decision Date2022-04-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DRPx Locking Distal Radius Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Implant Company. It received FDA 510(k) clearance on 2022-04-05 under 510(k) number K212601. 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 DRPx Locking Distal Radius Plate System?

DRPx Locking Distal Radius Plate System is a medical device that received FDA 510(k) clearance on 2022-04-05. The listed applicant is Orthopaedic Implant Company. The 510(k) number is K212601.

When did DRPx Locking Distal Radius Plate System receive FDA 510(k) clearance?

DRPx Locking Distal Radius Plate System received FDA 510(k) clearance on 2022-04-05, under 510(k) number K212601.

Who is the listed applicant for DRPx Locking Distal Radius Plate System?

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

What is the FDA product code for DRPx Locking Distal Radius Plate System?

The FDA product code for DRPx Locking Distal Radius Plate System is HRS.

Related Clinical Trials

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.

NCT07645768Is Anterior Reversed Proximal Humeral Locking Plate System (PHILOS) a Safe Alternative to Conventional Posterior Double Plating in Extra-Articular Distal Shaft Humeral FracturesACTIVE_NOT_RECRUITING

Other records listing Orthopaedic Implant Company 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.

K233531OIC FLEX-FIX™ SystemK223761OIC Intramedullary Screw SystemK223118OIC Variable Angle Small Fragment Locking Plate SystemK202971DRPx Locking Distal Radius Plate SystemK211112OIC External Fixation SystemK183682OIC External Fixation System

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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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