FDA Device Establishments · JSON-LD · Markdown

ORTEC Co., LTD.

FEI 3009119999 · Manufacture Medical Device · Status: Active

FEI Number3009119999
Owner / OperatorORTEC Co., LTD. (#10036960)
Address68 DEOKSANG-RO, SASANG-GU, Busan, 46939, KR
Mandatory US AgentLK Consulting Group USA, Inc.
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)ITQ
Regulation § (21 CFR)890.3475
Proprietary namesKnee Brace G3 ROM; Soft Knee Brace PCL; Soft Knee Brace MCL; Knee Brace OM ROM; Knee Brace ROM; Knee Brace Cadena ROM; Soft Knee Brace ACL; Knee Immobilizer; Knee Brace G5 ROM

External sources

Source: openFDA. Public-domain (CC0).