FDA Registration
Active
🇰🇷 South Korea
CnS MEDICAL CO., LTD.
Reg #: 3021519357
·
FEI: 3021519357
·
Expires 2026
Products
17
Proprietary Names
49
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- CnS MEDICAL CO., LTD.
- Registration Number
- 3021519357
- FEI Number
- 3021519357
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 94-40 Yongjeonggyeongje-ro 1-gil, Gunnae-myeon, Pocheon-si, Gyeonggi-do, Republic of Korea
- City
- Pocheon-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K242907
Owner / Operator
- Firm Name
- CnS MEDICAL Co., Ltd.
- Operator Number
- 10089381
- Address
- 94-40 Yongjeonggyeongje-ro 1-gil, Gunnae-myeon, Pocheon-si, Gyeonggi-do, Republic of Korea
- City
- Pocheon-si
- State
- Gyeonggi
- Postal Code
- 11154
- Country
- KR
- Correspondent
- SANGCHANG PARK
US Agent
- Business Name
- KMC USA, Inc
- Contact Name
- Jung Ryun Ahn
- Address
- 115 East 34th street, 13J
- City
- New York
- State
- NY
- ZIP
- 10016
- Country
- US
- [email protected]
- Phone
- 646 3576058
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2026-04-22 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2026-04-22 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2026-04-22 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2026-04-22 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2026-04-22 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2026-04-22 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2024-08-05 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2026-04-22 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2026-04-22 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2026-04-22 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2026-04-22 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2026-04-22 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2026-04-22 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-06-19 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2026-04-22 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2024-08-05 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2026-04-22 |
Proprietary Names
Endo Spade Knife
Spade Knife
eX Cage Impactor F
Endo Cage Impactor
Bone Chip Cannula & Impactor
Prep Reamer T
Prep Reamer
Prep Reamer Handle
Osteotome
Endo Cutting Forcep Short
Endo Cutting Forcep Long
Micro Pituitary
Pituitary 2 - Straight Type
Fan Dissector
Prep Dissector - Straight Type
Muscle Detacher - T-Bar
Endo Cob Dissector
Prep Dissector - Fan Type
Endo Dissector - Curved Type
CVD Dilator - MHSD-Bar
Prep Dissector - Curved Type
Double Ended Dissector
Endo Prep. Dissector
HA Delivery Tube
EW-1, ES-1
Scope Cannula Self-Retractor
Working Cannula Single
Working Cannula Transparent
Serial Dilator
Mallet
Foraminal CVD Kerrsion Punch
Kerrsion Punch
Rotatory K-Punch
Rotatory Foraminal CVD K-Punch
Dura Suture Pusher
Curette
Endo Ball Hook
Root Retractor
DELPHI System
Cage Guide
Dilator
Slap Hammer Remover - U
Slap Hammer Remover - J
eX Cage Guide
Bone Wax Delivery Tube
Cage Guide UFG
Solid
Prep Elevator - Curved
Prep Elevator - Straight
Establishment Types
Manufacture Medical Device