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Orthopedic Threaded Pin Fixation

by Osteomed Corp.

510(k) K932349

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 NumberK932349 Date1 Mar 1994ClearedStatusActive

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  • Withdrawn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
JDW
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Orthopedic Threaded Pin Fixation is a surgical fixation device designed to provide stable skeletal anchorage during orthopedic procedures. It functions as a threaded pin to secure bone fragments or implants in place, facilitating proper alignment and healing. The device is classified under product code JDW as a threaded fixation pin, intended for use in orthopedic surgery to achieve rigid internal fixation.

The device is supplied by Osteomed Corp. and was cleared under the FDA 510(k) premarket notification process with decision number K932349. It is a Class II medical device subject to special controls. The device is used in orthopedic surgical settings and is intended for single or multiple use as determined by the surgical protocol. Storage conditions and specific handling instructions are not detailed in the available regulatory data.

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Questions

AI-generated answers, 26 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 Orthopedic Threaded Pin Fixation used for?

    The Orthopedic Threaded Pin Fixation is designed to provide stable skeletal anchorage during orthopedic procedures. It functions as a threaded pin to secure bone fragments or implants in place, facilitating proper alignment and healing in orthopedic surgery.

  • How is the Orthopedic Threaded Pin Fixation supplied?

    The device is supplied by Osteomed Corp. as a Class II medical device subject to special controls. It is intended for single or multiple use as determined by the surgical protocol, though specific handling instructions are not detailed in the available regulatory data.

  • What is the regulatory status of this device?

    The Orthopedic Threaded Pin Fixation was cleared under the FDA 510(k) premarket notification process with decision number K932349. It is classified under product code JDW as a threaded fixation pin and received a decision of 'Substantially Equivalent' on March 1, 1994.

  • What are the storage conditions for this device?

    Storage conditions for the Orthopedic Threaded Pin Fixation are not detailed in the available regulatory data. Users should follow standard medical device storage protocols and consult the manufacturer's instructions for specific handling requirements.