Encore Linear Porous Coated Hip with Ha, Encore Foundation Porous Hip with Ha, Encore Revelation Porous Hip with Ha

• • Terminated Z-1128-04 FDA Unclassified (pre-2012) ·initiated 30 Jun 2004 ·on shared 510(k) K993943

  Hip stem product was mis-labeled with wrong size.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K993943 ↗

FDA Product Code

MEH

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 6.5 Mm Cancellous Bone Screw

  Class II

  FDA 510(k) K931665 Active Cleared 17 Feb 1994

• Berlin External Fixator

  Class II

  FDA 510(k) K954053 Active Cleared 16 May 1996

• Modification to Isobar Spinal System

  Class II

  FDA 510(k) K000020 Active Cleared 3 Feb 2000

• Foundation Knee Augmentation Blocks

  Class II

  FDA 510(k) K941306 Active Cleared 8 Feb 1995

• Foundation Porous Coated Hemispherical Shell

  Class II

  FDA 510(k) K974093 Active Cleared 28 Jan 1998

• Press-Fit Porous Shell

  Class II

  FDA 510(k) K961526 Active Cleared 17 Sep 1996

See all devices from Encore Orthopedics, Inc. →