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Aap Cannulated Screw 3.5MM, 4.0MM, 4.5MM, 7.0MM, 7.5MM

FDA 510(k)

Class II (US FDA 510(k))

510(k) K990776

by aap Implantate AG

Identifiers

510(k) Number
K990776 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Aap Cannulated Screw is a bone fixation device designed with a cannulated profile to facilitate insertion over a guide pin or wire. These screws are intended for use in orthopedic procedures to provide internal fixation of bone.

This device is supplied non-sterile and requires end-user steam sterilization according to AAMI/ISO 11737 guidelines to achieve a sterility assurance level of 10^-6. The screws are available in sizes 3.5mm, 4.0mm, 4.5mm, 7.0mm, and 7.5mm. This device has received FDA 510k clearance.

Frequently asked questions

What is the primary purpose of the Aap Cannulated Screw?

The Aap Cannulated Screw is an orthopedic bone fixation device designed with a hollow profile, which allows the surgeon to insert the screw precisely over a guide pin or wire during surgical procedures.

How is the device supplied and prepared for surgery?

These screws are supplied non-sterile. Before use, the end-user must perform steam sterilization following AAMI/ISO 11737 guidelines to ensure a sterility assurance level of 10^-6.

What size options are available for this screw system?

The Aap Cannulated Screw is available in five distinct diameters to accommodate various orthopedic fixation needs: 3.5mm, 4.0mm, 4.5mm, 7.0mm, and 7.5mm.

Is this device cleared for use by the FDA?

Yes, this device has received FDA 510k clearance under K990776, confirming it has been found substantially equivalent to predicate devices for internal bone fixation.

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: Aap Cannulated Screw, 7.5mm, 4.5mm, 4.0mm, 3.5mm, 7.0mm (K990776) — Fda ..., aap Implants Inc | Cannulated Screws 2.0 - 7.5, aap Implantate AG | Products, PDF K990776 - Aap Cannulated Screw, 7.5mm, 4.5mm, 4.0mm, 3.5mm, 7

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
aap Implantate AG

Sources (1)

  • FDA 510(k) K990776 24 fields · synced Oct 6, 2026