Omega Total Hip System for Use Without Bone Cement (Line Extension)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K964924 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Omega Ha Coated Total Hip System

  Class II

  FDA 510(k) K980981 Active Cleared 20 May 1998

• Omega Total Hip System for Cemented Applications

  Class II

  FDA 510(k) K960647 Active Cleared 17 Sep 1996

• OTI Modular Shoulder System

  Class II

  FDA 510(k) K982886 Active Cleared 5 Oct 1998

• Triad II Modular Total Hip System

  Class II

  FDA 510(k) K003199 Active Cleared 10 Jan 2001

• Omega II Modular Total Hip System

  Class II

  FDA 510(k) K984227 Active Cleared 8 Apr 1999

• Oti Femoral Lock Total Hip System

  Class II

  FDA 510(k) K982598 Active Cleared 2 Oct 1998

See all devices from Osteoimplant Technology, Inc. →