OsteoBridge IDSF System

• 3 recalls, same reason

  • Terminated Z-0436-2021 FDA Class II ·initiated 18 Sep 2020
  • Terminated Z-0437-2021 FDA Class II ·initiated 18 Sep 2020
  • Terminated Z-0438-2021 FDA Class II ·initiated 18 Sep 2020

  Product may be mislabeled.

1. 17 Oct 2018 Cleared FDA 510(k) K181026
2. 18 Sep 2020 Recall initiated FDA recalls Z-0436-2021
3. 18 Sep 2020 Recall initiated FDA recalls Z-0437-2021
4. 18 Sep 2020 Recall initiated FDA recalls Z-0438-2021

510(k) Number

K181026 ↗

FDA product code

HSB

Device class

Class II

Regulation

21 CFR Part 888.3020

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code HSB (Rod, Fixation, Intramedullary And Accessories).

• ORTHOFIX 1 99-67750350R by ORTHOFIX SRL
• PARTIALLY THREADED PEG TP26000 by Biomet Orthopedics, Inc.
• Long Trochanteric Nail System by DEPUY ORTHOPAEDICS, INC.
• Precice Stryde System by NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Fascilulated Nail by The Deca Co.
• Intramedullary Systems by Baumer Ortopedia, Ltd.
• CHIMAERA Hip Fracture System 1 99-T93615 by ORTHOFIX SRL
• Universal Tibial Nail II, Cannulated 071160330 by Double Medical Technology Inc.
• SMOOTH PEG P30000 by Biomet Orthopedics, Inc.
• Natural Nail® 47-2494-160-11 by Zimmer, Inc.

• MECRON™ Cannulated Screw 3.5 22 T10 short thread

  Class II

  FDA 510(k) K172213 Active Cleared 23 Oct 2017 GUDID on market

• MECRON™ Cannulated Screw 3.5 36 T10 full thread

  Class II

  FDA 510(k) K172213 Active Cleared 23 Oct 2017 GUDID on market

• Merete® CS Cortical Screw Fully Threaded 3.0 12 T10

  Class II

  FDA 510(k) K152187 Active Cleared 12 Feb 2016 GUDID on market

• K-Wires trocar tip round end 1.80 80

  Class II

  FDA 510(k) K120787 Active Cleared 27 Nov 2012 GUDID on market

See all devices from Merete GmbH →