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Bone Fixaction Screw

by Serrano Intl.

510(k) K810497

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK810497 Date11 Mar 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Bone Fixaction Screw is an orthopedic device used for bone fixation. It is substantially equivalent to other devices in its class.

The device is supplied with FDA 510(k) clearance, specifically with the k number K810497, and is classified under the product code HWC. It was cleared on March 11, 1981, and is manufactured by Serrano Intl.

Other devices from Serrano Intl.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Bone Fixaction Screw used for?

    The Bone Fixaction Screw is an orthopedic device used for bone fixation, providing a means to stabilize and align bones during the healing process.

  • Is the Bone Fixaction Screw supplied sterile?

    The device data does not specify sterility, it is essential to follow proper sterilization procedures before use.

  • What is the regulatory status of the Bone Fixaction Screw?

    The Bone Fixaction Screw has FDA 510(k) clearance, specifically with the k number K810497, indicating it is substantially equivalent to other devices in its class.