Cross-Over Acetabular Shell & Liner

• • Terminated Z-1066-2013 FDA Class II ·initiated 24 Jan 2013

  Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.

510(k) Number

K122773 ↗

FDA Product Code

OQG

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert

  Class II

  FDA 510(k) K173875 Active Cleared 19 Jan 2018

• Protract Press Fit Hip Stem

  Class II

  FDA 510(k) K003447 Active Cleared 15 Dec 2000

• Proform Cemented Femoral Component

  Class II

  FDA 510(k) K951083 Active Cleared 22 May 1995

• Dual Taper Wedge Pressed Fit Femoral Component

  Class II

  FDA 510(k) K953268 Active Cleared 17 Jan 1996

• Proven Knee System

  Class II

  FDA 510(k) K000113 Active Cleared 4 Apr 2000

• Stelkast Bipolar System

  Class II

  FDA 510(k) K972961 Active Cleared 4 Nov 1997

See all devices from Stelkast Company →