Medical Device Manufacturer · US , Raynham , MA

Omnilife Science - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2007

Recent clearances: Apex Knee System, OMNI ARC Anteverted Neck Hip Stem, OMNI Anseris Hip Stem

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Omnilife Science Orthopedic ✕

7 devices

1-7 of 7

Cleared Apr 02, 2021

Apex Knee System

Orthopedic · 291d

Cleared Dec 21, 2017

OMNI ARC Anteverted Neck Hip Stem

Orthopedic · 128d

Cleared Aug 17, 2017

OMNI Anseris Hip Stem

Orthopedic · 119d

Cleared Apr 26, 2017

Apex Revision Knee System

Orthopedic · 149d

Cleared Dec 21, 2015

Apex Revision Knee System

Orthopedic · 24d

Cleared Mar 13, 2014

OMNI ARC MONOBLOCK HIP STEM

Orthopedic · 129d

Cleared Aug 15, 2007

APEX HCLA ACETABULAR CUP LINERS

Orthopedic · 355d