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Bioretec Activascrew, Activascrew Cannulated And Activascrew Cannulated With Ac…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K081392

by Bioretec Ltd.

Identifiers

510(k) Number
K081392 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 ActivaScrew, ActivaScrew Cannulated, and ActivaScrew Cannulated with Activapin are orthopedic screws designed for internal fixation of bone fractures. These devices are intended to provide stable fixation in long bone fractures, including those requiring cannulated screws for minimally invasive techniques or additional fixation with an Activapin.

These screws are supplied sterile and intended for single-use in orthopedic surgical procedures. The cannulated versions allow for insertion over a guidewire, reducing soft tissue trauma, while the Activapin variant includes an additional fixation element. They are classified under the FDA’s orthopedic product code HWC and comply with the Medical Device Directive (MDD) and FDA 510(k) clearance as substantially equivalent to a predicate device.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bioretec Ltd.
FDA Applicant
Bioretec, Ltd.

Sources (2)

  • FDA 510(k) K081392 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026