FDA Registration
Active
🇰🇷 South Korea
SOLENDOS., INC.
Reg #: 3027262786
·
FEI: 3027262786
·
Expires 2026
Products
10
Proprietary Names
42
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- SOLENDOS., INC.
- Registration Number
- 3027262786
- FEI Number
- 3027262786
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #503 5F, E&C VENTURE DREAM TOWER3 38-21 DIGITAL-RO 31 GIL,, GURO-GU, SEOUL
- City
- GURO-GU Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K080560
Owner / Operator
- Firm Name
- Solendos., INC.
- Operator Number
- 10089428
- Address
- #503 5F, E&C VENTURE DREAM TOWER3 38-21 DIGITAL-RO 31 GIL,, GURO-GU, SEOUL, #505 5F, E&C VENTURE DREAM TOWER3 38-21 DIGITAL-RO 31 GIL,, GURO-GU, SEOUL
- City
- GURO-GU
- State
- Seoul
- Postal Code
- 08376
- Country
- KR
- Correspondent
- Soochul Kim
US Agent
- Business Name
- Cori Ragan
- Contact Name
- Cori Ragan
- Address
- 8 Moore Drive Durham, North Carolina
- City
- Durham
- State
- NC
- ZIP
- 27713
- Country
- US
- [email protected]
- Phone
- 612 4834578
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2023-12-07 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2024-12-03 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2023-12-07 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2023-12-07 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2023-12-07 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2023-12-07 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2023-12-07 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2024-11-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-12-07 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2023-12-07 |
Proprietary Names
[Target] TIK0001L Indian Knife(Long)
[Target] TML0001 Mallet
[Target] TCH0001L Straight Chisel 5mm
[Target] TCH0002L Hockey Chisel Left 5mm
[Target] TCH0004L Pedicle Chisel 4mm
[Target] TCH0003L Hockey Chisel Right 5mm
[Target] TMP0002 Micro Pituitary 2mm Up
[Target] TMP0001 Micro Pituitary 2mm Straight
[Target] TRP0002 Rotational Punch Head 3mm
[Target] TFP0001 Foraminal Punch 2mm
[Target] TFP0002 Foraminal Punch 3mm
[Target] TRP0001 Rotational Punch Head 2mm
[Target] TFR0001 Freer
[Target] TCU0005 Reverse Curette 3mm
[Target] TCU0002 Bone Curette 3mm Bishop
[Target] TCU0003 Bone Curette 5mm Maximus
[Target] TCU0006 Boomerang Curette 3mm
[Target] TCU0004 Bone Curette 6mm Wang
TA240-100
TA127-130
TA240-130
TA340-100
TA340-170
TA340-130
TA119-130
TA119-100
TA240-170
TA127-100
[Target] TSD0001-3 Serial Dilator
[Target] TSD0001-1 Serial Dilator
[Target] TSD0001 Serial Dilator Set
[Target] TDI0001 Dilator
[Target] TSD0001-2 Serial Dilator
[Target] TST0001 Sheath
[Target] TST0001-2 Obturator
[Target] TST0001-1 Obturator
[Target] TRR0001 Root Retractor
[Target] TUV0040 UV Retractor 40mm
[Target] TUV0050 UV Retractor 50mm
[Target] TUV0060 UV Retractor 60mm
[Target] TVP0002 Viewing portal Retractor curved
[Target] TVP0001 Viewing portal Retractor straight
Establishment Types
Repack or Relabel Medical Device