Conmed Linvatec Soft Tissue to Bone System

• • Terminated Z-0253-2018 FDA Class II ·initiated 17 Apr 2017

  Manufactured with the incorrect anchor outer body

510(k) Number

K091549 ↗

FDA Product Code

MBI

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• EndoPearl

  Class II

  FDA 510(k) K984171 Active Cleared 29 Apr 1999

• Trident Resection Ablator

  Class II

  FDA 510(k) K033748 Active Cleared 15 Dec 2003

• Linvatec 300W Xenon Light Source

  Class II

  FDA 510(k) K031994 Active Cleared 21 Aug 2003

• Cuto(Tm) Tissue Morcellation System

  Class I

  FDA 510(k) K932700 Active Cleared 15 Oct 1993

• El Lightwave Suction Ablator, Model El-2000-S, Lightwave Suction Ablator, Model Ia-2000-S, Lightwave Ablator, Model Ia-

  Class II

  FDA 510(k) K083281 Active Cleared 25 Feb 2009

• Resection Ablator

  Class II

  FDA 510(k) K013369 Active Cleared 4 Apr 2002

See all devices from Linvatec Corp. →