FDA Registration
Active
🇰🇷 South Korea
Aju Medical Co., Ltd.
Reg #: 3014232239
·
FEI: 3014232239
·
Expires 2026
Products
5
Proprietary Names
24
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Aju Medical Co., Ltd.
- Registration Number
- 3014232239
- FEI Number
- 3014232239
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 201, Room 207, BL A, 697, Pangyo-ro, Bundang-gu
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K193497
Owner / Operator
- Firm Name
- AJU Medical Co., Ltd.
- Operator Number
- 10056622
- Address
- Room 201, Room 207, BL A, 697, Pangyo-ro, Bundang-gu
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13511
- Country
- KR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-01-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2017-12-26 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2022-08-25 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2024-08-07 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2017-12-26 |
Proprietary Names
Fixone Biocomposite Interference Screw (I type)
Genesis Drill Guide
Genesis Dual Pitch AWL/Tapper
Genesis Drill Bit
Awl/Tapper
Dual Pitch Awl/Tapper
Drill Bit
Fixone Instrument
Genesis AWL/Tapper
Genesis AWL
Awl
Drill Guide
Fixone Hybrid Anchor (KP,KPN type)
AlternatiV+ Max Knotless Anchor (KPN type)
Genesis Knotless Anchor (KPN type)
Genesis Push-In Suture Anchor (S type)
Fixone Biocomposite Anchor (B,KC,S,SL,N,BN type)
AlternatiV+ Screw-In Anchor (BN type)
Genesis Screw-In Anchor (B type)
Genesis Dual Thread Screw-In Anchor (N type)
Fixone Meniscal Repair
Joinix Cannula
Fixone All Suture Anchor (J,JS,JM,JF type)
Genesis All Suture Anchor (JS type)
Establishment Types
Manufacture Medical Device