Opus Speedstitch Suture Device

• • Terminated Z-0611-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011

  Product is being removed from the field due to an over-label issue.

510(k) Number

K042031 ↗

FDA Product Code

GAT

Device Class

Class II

Regulation

21 CFR Part 878.5000

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Opus Magnum Knotless Anchor With Inserter Handle

  Class II

  FDA 510(k) K042914 Active Cleared 12 Nov 2004

• Opus Magnum Implant System, Model Om-1500

  Class II

  FDA 510(k) K031083 Active Cleared 12 Jun 2003

• F1 Diode Laser System

  Class II

  FDA 510(k) K030235 Active Cleared 23 Apr 2003

• Opus Magnum Anchor & Inserter

  Class II

  FDA 510(k) K012125 Active Cleared 17 Sep 2001

• Smartstitch M-Connector, Model Om-8005; Smartstitch Actuation Handle, Model Om-8500; and Smartstitch Suture Cartridge

  Class II

  FDA 510(k) K023843 Active Cleared 14 Feb 2003

• Opus Magnum Anchor with Inserter

  Class II

  FDA 510(k) K041440 Active Cleared 25 Jun 2004

See all devices from Opus Medical, Inc. →