FDA Registration
Active
🇰🇷 South Korea
ORTEC Co., LTD.
Reg #: 3009119999
·
FEI: 3009119999
·
Expires 2026
Products
9
Proprietary Names
65
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- ORTEC Co., LTD.
- Registration Number
- 3009119999
- FEI Number
- 3009119999
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 68 DEOKSANG-RO, SASANG-GU
- City
- Busan
- Country
- KR
Owner / Operator
- Firm Name
- ORTEC Co., LTD.
- Operator Number
- 10036960
- Address
- 68 DEOKSANG-RO, SASANG-GU
- City
- Busan
- State
- KR-NOTA
- Postal Code
- 46939
- Country
- KR
- Correspondent
- Byung-wook Ha
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 2552 Walnut Ave Ste 230
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
- [email protected]
- Phone
- 714 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2011-06-07 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2011-06-07 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2011-06-07 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2011-06-07 |
| Component, Cast | LGF | Class 1 | Orthopedic | No | 2011-06-07 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2011-06-07 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2011-06-07 |
| Cage, Knee | ITM | Class 1 | Physical Medicine | No | 2011-06-07 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2011-06-07 |
Proprietary Names
Long arm Brace
Tennis Elbow
Thumb Brace
Bobath Sling
Abduction Pillow
L-Sling
Kenny Howard
Ultra-Sling
Hemi Sling
B-Sling
O-Sling
Shoulder O-Sling
Hip Abduction
Dynamic splint
Finger Splint
Mallet Finger Splint
AFO
Air Cast
Knee Immobilizer
Soft Knee Brace PCL
Knee Brace G3 ROM
Soft Knee Brace MCL
Knee Brace G5 ROM
Knee Brace ROM
Knee Brace Cadena ROM
Soft Knee Brace ACL
Knee Brace OM ROM
T.L.S.O
Taylor 25
Molding Corset
Back Brace
VERTALOC TLSO BACK BRACE
L.S.O
35 Corset
OT-T.L.S.O
G-Corset(Low)
Back Brace 501
Low Back Brace
Taylor 400
V-Corset
25 Corset
High Back Brace
OT-Taylor
OT-Corset
Back Brace 210
Back Brace 505
Back Brace 400
OT- T.L.S.O(New)
B2 Back brace
Back Brace 260
Back Brace 110
OT-L.S.O (Molding)
G3 T.L.S.O
Halo Vest
G-Corset(High)
OT-L.S.O
30 Corset
B3 Back brace
Taylor
OT-Back Brace
High Chair Back
Low Chair Back
Knee Cage
Dynamic Splint
Palmar Splint
Establishment Types
Manufacture Medical Device