Orthotech Co L T D

FDA Filings

This page includes the latest FDA filings for Orthotech 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 Number3015136699
FEI Number3015136699
NameOrthotech Co, Ltd.
Owner & OperatorGBS Commonwealth, Co. Ltd.
Contact Address168 Gasan Digital 1-ro, Geumcheon-gu 309, Woolim Lions Valley C
Seoul KR-11 Seoul Teugbyeolsi 08507 KR
US Agent
Importing Logistics Registration
ImporterPMT Republic, Inc.
Address20616 Truss CT, Walnut, CA-917893879 US
City Industry, CA 91789 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address78 Yuram-ro, Dong-gu, Daegu, Rep. of Korea
Daegu Daegu Gwangyeogsi, 41059 KR
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Orthotech Co, Ltd. [GBS Commonwealth, Co. Ltd.]
Peridot Intervertebral body fusion system2019-12-03
Orthotech Co, Ltd. [GBS Commonwealth, Co. Ltd.]
The Prase MIS Spinal Fixaiton System2019-06-20
Orthotech Co, Ltd. [GBS Commonwealth, Co. Ltd.]
The Jasper Spinal Fixation System2019-06-20
Orthotech Co, Ltd. [GBS Commonwealth, Co. Ltd.]
THE JASPER Spinal Fixation System II2019-06-20
Orthotech Co, Ltd. [GBS Commonwealth, Co. Ltd.]
Jasper MIS Spinal System2019-06-20
Orthotech Co, Ltd. [GBS Commonwealth, Co. Ltd.]
THE Prase MIS Spinal System2018-12-04
Orthotech Co, Ltd. [GBS Commonwealth, Co. Ltd.]
THE JASPER Spinal Fixation System2018-12-04

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