The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Arix Hand Locking System.
| Device ID | K132876 |
| 510k Number | K132876 |
| Device Name: | ARIX HAND LOCKING 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 | Hyeroung Lee |
| Correspondent | Hyeroung Lee 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 | 2013-09-13 |
| Decision Date | 2013-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800089412037 | K132876 | 000 |
| 08800089411863 | K132876 | 000 |
| 08800089411856 | K132876 | 000 |
| 08800089411849 | K132876 | 000 |
| 08800089411832 | K132876 | 000 |
| 08800089411825 | K132876 | 000 |
| 08800089411818 | K132876 | 000 |
| 08800089411801 | K132876 | 000 |
| 08800089412297 | K132876 | 000 |
| 08800089412280 | K132876 | 000 |
| 08800089412273 | K132876 | 000 |
| 08800089412266 | K132876 | 000 |
| 08800089412259 | K132876 | 000 |
| 08800089412242 | K132876 | 000 |
| 08800089412228 | K132876 | 000 |
| 08800089411870 | K132876 | 000 |
| 08800089411887 | K132876 | 000 |
| 08800089412020 | K132876 | 000 |
| 08800089412013 | K132876 | 000 |
| 08800089412006 | K132876 | 000 |
| 08800089411993 | K132876 | 000 |
| 08800089411986 | K132876 | 000 |
| 08800089411979 | K132876 | 000 |
| 08800089411962 | K132876 | 000 |
| 08800089411955 | K132876 | 000 |
| 08800089411948 | K132876 | 000 |
| 08800089411931 | K132876 | 000 |
| 08800089411924 | K132876 | 000 |
| 08800089411917 | K132876 | 000 |
| 08800089411900 | K132876 | 000 |
| 08800089411894 | K132876 | 000 |
| 08800089412211 | K132876 | 000 |