Otis Biotech Co L T D

FDA Filings

This page includes the latest FDA filings for Otis Biotech Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005140381
FEI Number3005140381
NameMichael Van de Woude
Owner & OperatorOTIS BIOTECH CO., LTD
Contact Address15-118. MTV buk-ro, 193beon-gil, Building 14, 2nd floor
Siheung-Si KR-41 Gyeonggido 15118 KR
Official Correspondent
  • Kyle Kim
  • 82-031-3190406-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Michael Van de Woude [OTIS BIOTECH CO., LTD]
PROLIXUS TOTAL KNEE SYSTEM2017-12-06
OTIS Biotech Co., Ltd.
PROLIXUS TOTAL KNEE SYSTEM2017-11-09
Michael Van de Woude [OTIS BIOTECH CO., LTD]
MULTIFIT TOTAL HIP SYSTEM2011-02-11
Michael Van de Woude [OTIS BIOTECH CO., LTD]
MULTIFIT TOTAL HIP SYSTEM2011-02-11
Michael Van de Woude [OTIS BIOTECH CO., LTD]
MULTIFIT TOTAL HIP SYSTEM2011-02-11
Michael Van de Woude [OTIS BIOTECH CO., LTD]
MULTIFIT TOTAL HIP SYSTEM2011-02-11
OTIS BIOTECH CO., LTD
MULTIFIT TOTAL HIP SYSTEM2011-01-05
Michael Van de Woude [OTIS BIOTECH CO., LTD]
ULC SPINAL PEDICLE SCREW SYSTEM2009-12-24
Michael Van de Woude [OTIS BIOTECH CO., LTD]
ULC SPINAL PEDICLE SCREW SYSTEM2009-12-24
OTIS BIOTECH CO., LTD
ULC SPINAL PEDICLE SCREW SYSTEM2009-10-26

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