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ACE 3.5MM Cortical Bone Screw

FDA 510(k)

Class II (US FDA 510(k))

510(k) K905048

by Ace Medical Co.

Identifiers

510(k) Number
K905048 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 ACE 3.5MM Cortical Bone Screw is a fixation device used in orthopedic procedures. It is designed for securing bone fragments during surgical interventions.

This device is supplied as a single-use implant and is regulated under FDA 510(k) clearance with product code HWC. It is available in the 3.5mm size and was cleared as substantially equivalent on January 30, 1991.

Frequently asked questions

What is the ACE 3.5MM Cortical Bone Screw used for?

The ACE 3.5MM Cortical Bone Screw is a fixation device designed for securing bone fragments during orthopedic surgical interventions. It helps stabilize bones during the healing process.

Is the ACE 3.5MM Cortical Bone Screw single-use or reusable?

The ACE 3.5MM Cortical Bone Screw is supplied as a single-use implant. It should not be reused on different patients as this could compromise sterility and device integrity.

What sizes and models are available for the ACE Cortical Bone Screw?

The ACE Cortical Bone Screw is available in the 3.5mm size. This specific model was cleared as substantially equivalent on January 30, 1991, with product code HWC.

What is the regulatory status of the ACE 3.5MM Cortical Bone Screw?

The ACE 3.5MM Cortical Bone Screw is regulated under FDA 510(k) clearance. It was cleared as substantially equivalent on January 30, 1991, with product code HWC and K number K905048.

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: ACE 3.5MM CORTICAL BONE SCREW (K905048) — FDA 510(k) | Innolitics, ACE 3.5MM CORTICAL BONE SCREW 510(k) K905048 - FDA.report, Ace 3.5mm Cortical Bone Screw - Beudamed, PDF K905048 - ACE 3.5MM CORTICAL BONE SCREW - 510kdatabase.net, BONE PLATES & SCREWS 3.5MM - Ace Osteomedica

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ace Medical Co.

Sources (1)

  • FDA 510(k) K905048 24 fields · synced Oct 1, 2026