FDA Registration
Active
🇰🇷 South Korea
ARIX Hand Locking System
Reg #: 3004049923
·
FEI: 3004049923
·
Expires 2025
Products
1
Proprietary Names
38
Establishment Types
1
Classifications
1
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
- K132876
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
- [email protected]
- Phone
- 714 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2014-01-10 |
Proprietary Names
ARIX Hand Locking System
VERUM Hand System Bone Plate
VERUM Hand
VERUM System Bone Screw
INH2L-TP-007
IN20-HF-011
IN20L-HF-013
INH2L-LR-006
IN20-HF-008
IN20-HF-016
IN20L-HF-010
IN20L-HF-020
IN20-HF-013
IN20L-HF-016
IN20L-HF-006
IN20-HF-010
IN20L-HF-012
INLET New Hand System Bone Plate
IN20-HF-012
IN20L-HF-014
IN20L-HF-018
INH2L-LL-006
INH2L-QD-006
IN20L-HF-007
IN20-HF-007
IN20-HF-014
IN20L-HF-009
INH2L-YP-007
IN20-HF-020
INH2L-YP-006
INH2L-ST-006
IN20-HF-018
IN20-HF-009
IN20L-HF-011
INLET System Bone Screw
INH2L-ST-004
IN20-HF-006
IN20L-HF-008
Establishment Types
Manufacture Medical Device