FDA Registration Active 🇰🇷 South Korea

ARIX Hand System

Reg #: 3004049923 · FEI: 3004049923 · Expires 2025
Products
2
Proprietary Names
334
Establishment Types
1
Classifications
2

Registration Details

Registration Name
JEIL MEDICAL CORPORATION
Registration Number
3004049923
FEI Number
3004049923
Status
Active
Expiry Year
2025
Initial Importer
No
Address
702,703,704,705,706,707,804,805,807,812,815-ho, 55, Digital-ro 34-gil, Guro-gu,
City
Seoul
Country
KR

Regulatory Submissions

510(k) Number
K161746

Owner / Operator

Firm Name
JEIL MEDICAL CORPORATION
Operator Number
9053245
Address
702,703,704,705,706,707,804,805,807,812,815-ho, 55, Digital-ro 34-gil, Guro-gu
City
Seoul
State
KR-NOTA
Postal Code
08378
Country
KR
Correspondent
Jinwoo Kim

US Agent

Business Name
LK Consulting Group USA, Inc.
Contact Name
Priscilla Chung
Address
18881 Von Karman Ave STE 160
City
Irvine
State
CA
ZIP
92612
Country
US
Phone
714 2025789

Products

Device Name Product Code
Screw, Fixation, Bone HWC
Plate, Fixation, Bone HRS

Proprietary Names

ARIX Hand System SO-20L-HF-018 SO-23-FC-006 SO-H2L-LR-010-13 PH2012 PH1060 PH0912 VERUM HAND SO-15L-HF-012 SO-15-HC-014 PH1506-L PH1508-H1 PH2008-L PH1150 SO-15-HC-018 PH1508-L PH1510-H1 PH2010-L SO-15L-HF-007 SO-H1L-ST-104 PH1516-L PH1100 SO-15L-HF-014 SO-H2L-ST-006 SO-H2L-LL-006-13 PH1030 PH1170 SO-23-FC-010 PH2013 PH1070 SO-15L-HF-020 SO-H2L-TP-007 SO-15L-HF-018 SO-H2L-QD-006 PH1513-H1 PH1200 SO-20-HF-012 SO-H1L-LL-005 SO-H2L-ST-208-13 PH1512-H1 PH1050 PH1190 PH1000 SO-20L-HF-013 SO-20-HF-016 PH2007-L PH2009 SO-15-HC-007 SO-20L-HF-007 SO-H2L-YP-007 SO-15L-HF-008 SO-H1L-QD-112 PH1516-H1 PH1220 PH1518-L PH1110 SO-20L-HF-014 SO-20-HF-018 Summa Orthopaedics Hand System Bone Plate PH2010 PH0910 SO-H1L-ST-006 SO-15L-HF-009 SO-15-HC-011 SO-H1L-TP-007 SO-15L-HF-010 SO-15-HC-012 PH2014 PH1080 PH1520-L PH1120 PH1260 PH1506-H1 PH1130 VERUM Hand System Bone Plate SUMMA Hand Locking System VERUM System Bone Screw SO-20-HF-010 SO-H2L-ST-105-13 PH2018-L PH2306 SO-15-HC-006 SO-H2L-YP-006 PH1514-H1 PH1210 SO-20L-HF-016 SO-20-HF-020 SO-H2L-LL-010-13 SO-15-HC-010 SO-20L-HF-010 PRO-10563 PRO-10577 PRO-10616 PH1806-H1 PH2006 PH1250 PH2011 SO-15-HC-016 PH0911 SO-15L-HF-006 SO-H1L-ST-016 PH1507-L PH1509-H1 PH2009-L PH1514-L PH2016 PH1090 SO-18-HC-006 SO-20-HF-006 PH1510-L PH2012-L PH0914 SO-20-HF-011 SO-H1L-YP-006 SO-H2L-ST-106-13 SO-20L-HF-012 SO-20L-HF-006 SO-20-HF-008 SO-H2L-LR-006 PH2020-L PH2310 PH1512-L PH2014-L PH2018 PH2006-L PH2008 SO-20-HF-009 SO-H2L-ST-104-13 PH1513-L PH2016-L PH2020 SO-15L-HF-013 SO-20-HF-014 SO-H2L-ST-004 SO-H2L-TP-010-13 PRO-10586 PRO-10600 PRO-10628 PRO-10602 PH1020 PRO-10630 PH1160 SO-15L-HF-011 SO-15-HC-013 PH1507-H1 PH1140 SO-15-HC-020 SO-20L-HF-020 SO-15-HC-008 SO-20L-HF-008 PH1509-L PH1511-H1 PH2011-L PH0913 PH1518-H1 PH1230 SO-15L-HF-016 SO-H2L-ST-016 SO-H2L-LR-006-13 SO-15-HC-009 SO-20L-HF-009 PH1520-H1 PH1240 PH1040 PH1180 SO-20L-HF-011 PH1810-H1 PH2007 SO-18-HC-010 SO-20-HF-007 SO-H2L-LL-006 PRO-10564 PRO-10578 PH1511-L PH2013-L SO-20-HF-013 SO-H1L-LR-005 SO-H2L-TP-006-13 PRO-10591 PH1010 PRO-10576 PRO-10590 PRO-10571 PRO-10624 PRO-10574 PRO-10588 PRO-10581 PRO-10584 PRO-10598 Summa Orthopaedics System Bone Screw PRO-10565 PRO-10579 PRO-10560 PRO-10613 PRO-10561 PRO-10614 PRO-10593 PRO-10607 Prometheus Hand System Bone Plate PRO-10582 PRO-10583 PRO-10597 PRO-10592 Prometheus System Bone Screw PRO-10557 PRO-10596 PRO-10610 PRO-10601 PRO-10629 PRO-10566 PRO-10580 PRO-10555 PRO-10569 PRO-10622 PRO-10604 PRO-10618 PRO-10554 PRO-10568 PRO-10621 PRO-10585 PRO-10599 PRO-10627 PRO-10562 PRO-10615 PRO-10559 PRO-10612 PRO-10556 PRO-10570 PRO-10623 PRO-10603 PRO-10617 PRO-10631 PRO-10553 PRO-10567 PRO-10606 PRO-10620 INH2L-LR-006-13 PRO-10575 PRO-10589 PRO-10573 PRO-10587 PRO-10626 PRO-10595 PRO-10609 PRO-10605 PRO-10619 PRO-10594 PRO-10608 PRO-10558 PRO-10611 IN15-HC-007 IN15-HC-014 IN20-HF-011 IN20L-HF-013 PRO-10572 PRO-10625 IN112-104 INH1L-ST-006 IN15L-HF-009 INH2L-LL-006-13 IN15-HC-020 IN20L-HF-018 INH1L-QD-112 IN20-HF-020 INH1L-LL-005 IN15-HC-012 IN20-HF-018 IN20L-HF-011 INH2L-ST-106-13 IN20-HF-009 INH2L-ST-208-13 INH1L-ST-104 INH2L-ST-004 IN15L-HF-010 IN15L-HF-020 IN15-HC-018 IN20-HF-013 IN20L-HF-016 INH2L-LL-006 IN15L-HF-012 IN23-FC-006 INLET System Surgical Instrument INH2L-ST-016 IN18-HC-006 INH2L-LR-006 IN15L-HF-014 INLET System Bone Screw INH2L-LL-010-13 IN15L-HF-006 IN15L-HF-013 IN23-FC-010 INH2L-TP-010-13 INH1L-ST-016 IN20L-HF-006 IN15-HC-016 IN20-HF-012 IN20L-HF-014 INH2L-YP-007 IN15-HC-009 IN20-HF-006 IN20L-HF-008 INH2L-TP-006-13 IN15-HC-006 IN15-HC-013 IN20-HF-010 IN20L-HF-012 INH2L-LR-010-13 INH2L-TP-007 IN15L-HF-016 INH1L-LR-005 IN15L-HF-008 INH2L-QD-006 IN15-HC-008 IN15L-HF-018 IN20L-HF-007 INH1L-TP-007 INH2L-ST-105-13 IN18-HC-010 IN15L-HF-007 IN15-HC-010 IN20-HF-007 IN20-HF-014 IN20L-HF-009 INLET New Hand System Bone Plate INH2L-ST-104-13 INH2L-YP-006 INH1L-YP-006 INH2L-ST-006 IN15L-HF-011 IN15-HC-011 IN20-HF-008 IN20-HF-016 IN20L-HF-010 IN20L-HF-020

Establishment Types

Manufacture Medical Device