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Bone Fragment and Fixation Plates, Screws and Washers

by Laura Cattabriga

510(k) K130614

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 NumberK130614 Date17 Jan 2014ClearedStatusActive

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  • Withdrawn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
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
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 Bone Fragment and Fixation Plates, Screws and Washers are orthopedic devices classified as Plate, Fixation, Bone. These devices include metallic plates, screws, and washers designed to stabilize and align fractured bone fragments, aiding in proper healing by maintaining anatomical reduction during bone consolidation.

Supplied sterile and intended for single-use, these devices are classified under the HRS product code and regulated under FDA 510(k) clearance (K130614). The Orthopedic Advisory Committee determined the device Substantially Equivalent (SESE) to its predicate, adhering to FDA Special Controls for Class II orthopedic hardware. Proper sterile storage and handling are required prior to surgical use.

Bone Fragment and Fixation Plates, Screws and Washers

Other devices from Laura Cattabriga

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 Bone Fragment and Fixation Plates, Screws and Washers used for?

    These devices are designed to stabilize and align fractured bone fragments during the healing process. By maintaining proper anatomical reduction, the metallic plates, screws, and washers help ensure bones consolidate correctly, reducing the risk of misalignment or improper healing.

  • Are the Bone Fragment and Fixation Plates, Screws and Washers sterile and single-use?

    Yes, these devices are supplied sterile and intended for single-use only. Sterility is critical for surgical applications, and single-use ensures patient safety by preventing cross-contamination between procedures.

  • How are these devices regulated and cleared by the FDA?

    The Bone Fragment and Fixation Plates, Screws and Washers are classified under the HRS product code and have received FDA 510(k) clearance (K130614). The Orthopedic Advisory Committee determined the device Substantially Equivalent (SESE) to its predicate, adhering to FDA Special Controls for Class II orthopedic hardware.

  • What storage and handling requirements apply to these devices?

    Proper sterile storage and handling are mandatory prior to surgical use. This ensures the devices remain uncontaminated and maintain their integrity, which is essential for safe and effective orthopedic fixation during surgery.

  • What distinguishes this product from other orthopedic fixation systems?

    This product is specifically manufactured by Laura Cattabriga and cleared under FDA 510(k) clearance (K130614). The inclusion of metallic plates, screws, and washers tailored for bone fragment stabilization sets it apart, ensuring precise alignment and secure fixation during the healing process.