PediatrOS RigidTack/FlexTack

• • Terminated Z-0650-2022 FDA Class II ·initiated 18 Jan 2022

  Incorrect marketing label (25 mm) was applied to product size 20 mm.

510(k) Number

K151762 ↗

FDA Product Code

JDR

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Merete Twistcut Snap-Off Bone Screw

  Class II

  FDA 510(k) K051323 Active Cleared 7 Jul 2005

• Bioball Delta Ceramic Heads, Multicup Pe Inlay Standard

  Class II

  FDA 510(k) K141377 Active Cleared 21 Nov 2014

• Metafix Blp Plate, Size 31, Left, Metafix Blp Plate, Size 31, Right

  Class II

  FDA 510(k) K132226 Active Cleared 9 Aug 2013

• Merete Locking Bone Plate System III

  Class II

  FDA 510(k) K120787 Active Cleared 27 Nov 2012

• Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation System

  Class II

  FDA 510(k) K101939 Active Cleared 7 Oct 2010

• Merete Locking Bone Plate System

  Class II

  FDA 510(k) K090063 Active Cleared 22 Apr 2009

See all devices from Merete Medical GmbH →