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Metal Bone Screw

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220921

by Double Medical Technology Inc.

Identifiers

510(k) Number
K220921 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)

This device is a metal bone screw classified under orthopedic nomenclature, designed for internal bone fixation. It provides mechanical stability to fractured or surgically altered bone segments by threading into cortical or cancellous bone, facilitating proper alignment and healing. Constructed from cobalt-chromium-molybdenum alloy (CoCrMo), it is intended for load-bearing applications where secure fixation is required.

The screw is supplied as a single-use, sterile device and is intended for use in orthopedic surgical settings. Available in a 7.3mm diameter, it is fully threaded to maximize grip and is non-locking, allowing for adjustable positioning. Compliance is confirmed through FDA 510(k) clearance (K220921) and adherence to the Medical Device Directive (MDD). Storage and handling must follow sterile medical device protocols to maintain integrity prior to use.

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: Products - Double Medical, K220921 - Metal Bone Screw - Orthopedic, Home - Double Medical, Double Medical Technology Inc. 040120085 7.3mm Non-locking Screw, Fully ..., Double Medical Technology, Inc. — FDA Actions | RecallHawk

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Double Medical Technology Inc.
FDA Applicant
Double Medical Technology, Inc.

Sources (2)

  • FDA 510(k) K220921 24 fields · synced Sep 20, 2026
  • EUDAMED 1 fields · synced May 19, 2026