← Back to catalogue

LOQTEQ Large Fragment Set LOQTEQ Cortical Screw 4.5, Small Head, T25, Self Tapping

FDA 510(k)

Class II (US FDA 510(k))

510(k) K113648

by aap Implantate AG

Identifiers

510(k) Number
K113648 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)

This device is an orthopedic implant system for bone fracture fixation. It comprises titanium bone plates and screws, specifically cortical screws of 4.5 mm diameter with a small head and T25 drive, designed for self-tapping application in large fragment fixation.

The device is supplied as part of the LOQTEQ Large Fragment Set and is intended for use in surgical settings for internal fixation of bone fractures. It is a reusable implant system component, with no indication of sterility, single-use status, MRI safety, or specific storage conditions provided in the data. Authorization is based on FDA 510(k) clearance under K113648, with product code HRS and classification under the Orthopedic advisory committee.

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: Loqteq Large Fragment Set Loqteq Cortical Screw 4.5, Small Head, T25 ..., aap Implantate AG | LOQTEQ® Plating System, Large bone fragment compression plate - LOQTEQ® 4.5 - aap Implantate ..., PDF ST_LOQTEQ_Straight_Plates_3.5_4.5_E_2011-2_final_view - aap

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
aap Implantate AG

Sources (1)

  • FDA 510(k) K113648 24 fields · synced Oct 6, 2026