FDA.reportPublic FDA data

Orthotech Co, Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30151366993015136699Orthotech Co, Ltd.1N2020-04-2578 Yuram-ro, Dong-gu, Daegu, Rep. of Korea Daegu Daegu Gwangyeogsi KR 41059

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2249431976123023K192026Peridot Intervertebral body fusion SystemMAX2019-11-26
2249431193035327K190762The JASPER Spinal Fixation System IINKB2019-06-19
2249431080913310K182059Prase MIS Spinal SystemNKB2018-10-04
2249432044634697K173645JASPER Spinal Fixation SystemNKB2018-07-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB32019-06-19
MAX12019-11-26