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REVCON Screw System

by Voom Medical Devices, Inc

510(k) K223392

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 NumberK223392 Date28 Feb 2023ClearedStatusActive

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  • Withdrawn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)

Full name
REVCON (TM) Screw System
510(k) Number
FDA product code
HWC
FDA applicant
Voom Medical Devices, Inc.
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Revcon Screw System is a bone fixation device classified as a Screw, Fixation, Bone (product code HWC). It is designed for orthopedic applications, providing internal fixation to stabilize bone fragments or joints, particularly in procedures such as minimally invasive bunion surgery.

This device is supplied as a sterile, single-use system and is intended for use in controlled surgical environments. It has received FDA 510(k) clearance under the Traditional review pathway, with a decision date of February 28, 2023. The system is intended for Class II orthopedic fixation and adheres to special controls as defined by regulatory standards.

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Questions

AI-generated answers, 1 Oct 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 Revcon™ Screw System used for?

    The Revcon™ Screw System is designed for orthopedic applications to provide internal fixation and stabilize bone fragments or joints. It is particularly suited for procedures such as minimally invasive bunion surgery, ensuring secure alignment and support during the healing process.

  • Is the Revcon™ Screw System sterile and single-use?

    Yes, the Revcon™ Screw System is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintains the integrity of the fixation system for a single surgical procedure.

  • How is the Revcon™ Screw System supplied?

    The system is packaged and intended for use in controlled surgical environments. It is pre-sterilized to meet medical-grade standards, allowing for immediate use once the packaging is opened under sterile conditions.

  • What regulatory pathway did the Revcon™ Screw System follow?

    The Revcon™ Screw System received FDA 510(k) clearance under the Traditional review pathway, demonstrating substantial equivalence to a predicate device. This pathway ensures compliance with regulatory standards for Class II orthopedic fixation devices.

  • Are there different sizes or models available for the Revcon™ Screw System?

    The provided specifications do not detail specific sizes or models, but the system is designed for general orthopedic fixation. For precise sizing or model-specific details, refer to the manufacturer’s technical documentation or consult with a medical representative.