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Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System

by Merete Medical GmbH

510(k) K051965

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 NumberK051965 Date16 Jun 2006ClearedStatusActive

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  • Withdrawn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
HSB
Device Class
Class II
Regulation
21 CFR Part 888.3020
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System is a modular diaphyseal implant used for long term stabilization of segmental bone defects in the humerus, femur, and tibia. It consists of a spacer that fixates two intramedullary nails and bridges the defect after resection.

The system is intended for use in the management of segmental diaphyseal bone loss secondary to radical bone loss and/or resection due to tumors in oncology patients. It is divided into three categories or product size ranges, suitable for each bony application. The device has received FDA 510K authorization.

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Questions

AI-generated answers, 25 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 Osteobridge Idsf Rod System used for?

    The Osteobridge Idsf Rod System is used for long term stabilization of segmental bone defects in the humerus, femur, and tibia, particularly in cases of radical bone loss and/or resection due to tumors in oncology patients.

  • Is the Osteobridge Idsf Rod System a single-use device?

    The description does not explicitly state whether the Osteobridge Idsf Rod System is single-use or reusable, but it is intended for long term stabilization of segmental bone defects.

  • What sizes or product ranges are available for the Osteobridge Idsf Rod System?

    The Osteobridge Idsf Rod System is divided into three categories or product size ranges, suitable for each bony application, including the humerus, femur, and tibia.