The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Arix Hand System.
Device ID | K131566 |
510k Number | K131566 |
Device Name: | ARIX HAND SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | JEIL MEDICAL CORPORATION #702, KOLON SCIENCE VALLEY 2ND 811, GURO-DONG, GURO-GU Seoul-city, KR 152-050 |
Contact | Ji-eun Kim |
Correspondent | Ji-eun Kim JEIL MEDICAL CORPORATION #702, KOLON SCIENCE VALLEY 2ND 811, GURO-DONG, GURO-GU Seoul-city, KR 152-050 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-30 |
Decision Date | 2013-11-04 |
Summary: | summary |