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FDA 510(k)

OIC Variable Angle Small Fragment Locking Plate System

K-Number: K223118 · 2023-01-21

ApplicantOrthopaedic Implant Company
Decision Date2023-01-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OIC Variable Angle Small Fragment Locking 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 2023-01-21 under 510(k) number K223118. 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 OIC Variable Angle Small Fragment Locking Plate System?

OIC Variable Angle Small Fragment Locking Plate System is a medical device that received FDA 510(k) clearance on 2023-01-21. The listed applicant is Orthopaedic Implant Company. The 510(k) number is K223118.

When did OIC Variable Angle Small Fragment Locking Plate System receive FDA 510(k) clearance?

OIC Variable Angle Small Fragment Locking Plate System received FDA 510(k) clearance on 2023-01-21, under 510(k) number K223118.

Who is the listed applicant for OIC Variable Angle Small Fragment Locking 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 OIC Variable Angle Small Fragment Locking Plate System?

The FDA product code for OIC Variable Angle Small Fragment Locking Plate System is HRS.

Other records listing Orthopaedic Implant Company 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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