FDA.reportPublic FDA data

ORTHOTECH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30316064163031606416ORTHOTECH REHABILITATION CO., LTD.1N2026-01-01Building #1, No. 69 Xinyuan South Rd., Xinyang Industry Section, Xiamen Fujian CN 361000
30420284803042028480ORTHOTECH ORTHOPEDIC GROUP LLC1Y2026-01-01#35 Calle Ingenio Rochelaise Center Carr. 114 km 0.4 Western Indus Mayaguez PR US 00682
30422051433042205143ORTHOTECH CO., LTD.1N2026-01-01100-4, Cheombok-ro Dong-Gu Daegu KR 41061
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
3290101010718703
3290101015804590
3290101023591763
3290101042653724
3290101144385261
3290101200531971
3290101231297589
3452001243283696
3290101277887224
3290101289987740
3290101361299330
3290101427263969
3290101467490840
3452001481592814
3290101546654938
3290101573294451
3290101596995258
3290101657297327
3290101729424262
3290101738269556
3290101769641451
3290101800084938
3290101817809830
3452001871397840
3290101918506362
3290101938605916
3290101988596932
3290101995208166
3290102044122539

Product Codes Associated With Registrations#

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

PMN#