Medical Device Manufacturer · US , Dallas , TX

Howmedica Leibinger, Inc. - FDA 510(k) Cleared Devices

11 submissions · 10 cleared · Since 1996

Recent clearances: LEIBINGER SELF-DRILLING SCREW, COHEN DISTRACTOR, GUERRERO - BELL DISTRACTOR

11

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Howmedica Leibinger, Inc. Orthopedic ✕

4 devices

1-4 of 4

Cleared Oct 01, 1997

LEIBINGER SELF-DRILLING SCREW

Orthopedic · 203d

Cleared Jul 17, 1997

EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES

Orthopedic · 441d

Cleared Feb 06, 1997

LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS

Orthopedic · 142d

Cleared Jan 22, 1997

LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS

Orthopedic · 127d