Medical Device Manufacturer · KR , Siheung-Si, Gyounggi-Do

Otis Biotech Co., Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2009

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Otis Biotech Co., Ltd. Orthopedic ✕

3 devices

1-3 of 3

Cleared Nov 09, 2017

PROLIXUS TOTAL KNEE SYSTEM

Orthopedic · 259d

Cleared Jan 05, 2011

MULTIFIT TOTAL HIP SYSTEM

Orthopedic · 223d

Cleared Oct 26, 2009

ULC SPINAL PEDICLE SCREW SYSTEM

Orthopedic · 375d