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IFS Bone Fixation Devices

by Internal Fixation Systems, Inc.

510(k) K071035

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 NumberK071035 Date13 Aug 2007ClearedStatusActive

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  • Withdrawn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, 28 Sep 2026

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

IFS Bone Fixation Devices are indicated for use in fixation of bone fractures, bone reconstructions, and as guide pins for insertion of other implants or implantation through the skin to apply traction to the skeletal system. The devices consist of metallic cancellous, malleable, and cortical screws with lengths ranging from 6-160mm and diameters from 1.5-7.3mm, as well as guide wires.

The IFS washers are provided non-sterile and are intended to prevent a screw head from breaking through the cortex of the bone by distributing forces over an area during fracture fixation of small bones and bone fragments. The devices are manufactured by Internal Fixation Systems, Inc. and received FDA 510(k) clearance with K number K071035 on August 13, 2007.

Other devices from Internal Fixation Systems, Inc.

Questions

AI-generated answers, 28 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 are IFS Bone Fixation Devices used for?

    IFS Bone Fixation Devices are indicated for fixation of bone fractures, bone reconstructions, and as guide pins for insertion of other implants or implantation through the skin to apply traction to the skeletal system.

  • What sizes and types of devices are included in the IFS Bone Fixation System?

    The system includes metallic cancellous, malleable, and cortical screws with lengths ranging from 6-160mm and diameters from 1.5-7.3mm, as well as guide wires. The washers are provided non-sterile.

  • What is the purpose of the IFS washers included in the system?

    The IFS washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing forces over an area during fracture fixation of small bones and bone fragments.

  • What is the regulatory status of IFS Bone Fixation Devices?

    The devices received FDA 510(k) clearance with K number K071035 on August 13, 2007, and are manufactured by Internal Fixation Systems, Inc. in Miami, Florida.