Zirconium Alloy Uni-Polar Head

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K934353 ↗

FDA Product Code

KWL

Device Class

Class II

Regulation

21 CFR Part 888.3360

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Hydrocell Nasal and Sinus Packs

  Class I

  FDA 510(k) K954491 Active Cleared 15 Nov 1995

• Black Oval-Top Torp/Porp

  Class II

  FDA 510(k) K934107 Active Cleared 8 Jun 1994

• Profix Conforming Plus Tibial Insert

  Class II

  FDA 510(k) K946236 Active Cleared 6 Jul 1995

• Epistaxis Nasal Balloon Catheter

  Class I

  FDA 510(k) K921199 Active Cleared 8 Jul 1992

• Geri Total Hip System

  Class II

  FDA 510(k) K905186 Active Cleared 15 Feb 1991

• Rihards Titanium Half Pin

  Class II

  FDA 510(k) K920024 Active Cleared 21 Jan 1992

See all devices from Smith & Nephew Richards, Inc. →