Skip to content

Baumer Pins

by Baumer Ortopedia, Ltd. Brazil 510(k)

510(k) K930969

Product code HTY

Overview

The Baumer Pins are orthopedic fixation devices designed for internal skeletal stabilization. These pins are intended for use in orthopedic procedures to provide rigid fixation of bone fragments, aiding in the healing process of fractures or surgical reconstructions.

These pins are supplied sterile and intended for single-use. They are classified under product code HTY and were granted FDA 510(k) clearance under the Traditional 510(k) review pathway as substantially equivalent to a predicate device. The device is regulated under orthopedic guidelines and requires proper handling and storage to maintain sterility and integrity prior to use.

Summary written by AI from registry data, 19 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK930969 Date29 Mar 1994ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
HTY
FDA applicant
Baumer Ortopedia , Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Baumer Ortopedia, Ltd.

Questions

  • What are the Baumer Pins primarily used for in orthopedic procedures?

    The Baumer Pins are orthopedic fixation devices designed to provide rigid stabilization of bone fragments during surgical procedures. They are specifically intended to aid in the healing process of fractures or during reconstructive surgeries by holding bones securely in place.

  • Are the Baumer Pins meant for single-use or can they be reused?

    The Baumer Pins are explicitly supplied sterile and intended for single-use only. Reusing them could compromise sterility and compromise patient safety, so proper disposal after one use is required.

  • How should I store the Baumer Pins to ensure they remain sterile and intact?

    The Baumer Pins must be stored according to manufacturer guidelines to maintain sterility and integrity. Since they are sterile upon supply, they should be kept in their original packaging until use, protected from contamination, moisture, and physical damage.

  • What regulatory pathway was followed for FDA clearance of the Baumer Pins?

    The Baumer Pins were granted FDA clearance through the Traditional 510(k) review pathway, determined to be substantially equivalent to a predicate device. The submission was reviewed by the Orthopedic (OR) Advisory Committee and classified under product code HTY.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K930969 24 fields · synced 22 Oct 2026