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Renovis Cannulated Screw System

by Renovis Surgical Technologies, LLC

510(k) K113084

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 · Special NumberK113084 Date9 Dec 2011ClearedStatusActive

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  • Withdrawn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, 24 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 Renovis Cannulated Screw System consists of cannulated screws and washers for bone fixation, facilitating accurate placement over guide pins. It provides secure fixation for fractures, osteotomies, and arthrodesis.

The system includes screws available in various diameters and lengths in partially threaded or fully threaded designs, along with washers. It is supplied as a sterile device and is intended for single use. The device received FDA 510(k) clearance with product code HWC.

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Questions

AI-generated answers, 24 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 Renovis Cannulated Screw System used for?

    The Renovis Cannulated Screw System is used for bone fixation in fractures, osteotomies, and arthrodesis procedures, facilitating accurate placement over guide pins to provide secure fixation.

  • How is the Renovis Cannulated Screw System supplied and is it reusable?

    The Renovis Cannulated Screw System is supplied as a sterile device and is intended for single use only, ensuring each component is used once to maintain sterility and prevent cross-contamination.

  • What components are included in the Renovis Cannulated Screw System?

    The system includes cannulated screws available in various diameters and lengths in both partially threaded and fully threaded designs, along with washers, all designed for bone fixation applications.