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OIC Variable Angle Small Fragment Locking Plate System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K140357

by Orthopaedic Implant Company

Identifiers

510(k) Number
K140357 FDA 510(k)
FDA Product Code
HRS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The OIC Variable Angle Small Fragment Locking Plate System is an orthopedic fixation device consisting of pre-contoured titanium alloy or cp titanium plates and bone screws. The plates are designed to match the specific anatomy of the distal radius, clavicle, proximal humerus, tibia, and distal fibula, providing targeted support for fracture fixation.

The system includes screws with 2.5mm diameter and lengths ranging from 6mm to 130mm, available with locking or non-locking heads. The device is supplied in clinical or OR settings for use by orthopedic surgeons and is intended for single-use applications.

Frequently asked questions

What is the OIC Variable Angle Locking Plate System used for?

The OIC Variable Angle Locking Plate System is used for fracture fixation, providing targeted support for specific anatomies such as the distal radius, clavicle, and proximal humerus.

What materials are the plates and screws made of?

The plates are made of titanium alloy or cp titanium, and the screws have a 2.5mm diameter with lengths ranging from 6mm to 130mm.

Is the OIC Variable Angle Locking Plate System intended for single or multiple uses?

The device is intended for single-use applications in clinical or OR settings by orthopedic surgeons.

What types of screws are available with the system?

The system includes screws with locking or non-locking heads, providing flexibility for different fracture fixation needs.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Oic Variable Angle Small Fragment Locking Plate System, OIC Variable Angle Small Fragment Locking Plate System, OIC Variable Angle Small Fragment Locking Plate System 510 (k) K223118 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Orthopaedic Implant Company

Sources (1)

  • FDA 510(k) K140357 24 fields · synced Sep 25, 2026