FDA Registration
Active
🇺🇸 United States
CGBIO USA, INC.
Reg #: 3039103971
·
FEI: 3039103971
·
Expires 2026
Products
10
Proprietary Names
33
Establishment Types
1
Classifications
10
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Registration Details
- Registration Name
- CGBIO USA, INC.
- Registration Number
- 3039103971
- FEI Number
- 3039103971
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 41 Corporate Park Ste 200
- City
- Irvine
- State
- CA
- ZIP
- 92606
- Country
- US
Regulatory Submissions
- 510(k) Number
- K252251
Owner / Operator
- Firm Name
- CGBIO USA, Inc.
- Operator Number
- 10094982
- Address
- 41 Corporate park, suite 200
- City
- Irvine
- State
- CA
- Postal Code
- 92606
- Country
- US
- Correspondent
- Jumi Han
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2026-01-27 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2026-01-27 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2026-01-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2026-01-27 |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | Class 2 | Neurology | No | 2026-05-13 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2026-01-27 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2026-01-27 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2026-01-27 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2026-01-27 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2026-01-27 |
Proprietary Names
[Target] TFR0001 Freer
[Target] TML0001 Mallet
[Target] TCH0001L Straight Chisel 5mm
[Target] TCH0004L Pedicle Chisel 4mm
[Target] TCH0002L Hockey Chisel Left 5mm
[Target] TCH0003L Hockey Chisel Right 5mm
[Target] TST0001-2 Obturator
[Target] TSD0001-3 Serial Dilator
[Target] TSD0001-1 Serial Dilator
[Target] TST0001 Sheath
[Target] TST0001-1 Obturator
[Target] TDI0001 Dilator
[Target] TSD0001-2 Serial Dilator
[Target] TSD0001 Serial Dilator Set
EASYMADE-TI
[Target] TCU0006 Boomerang Curette 3mm
[Target] TCU0005 Reverse Curette 3mm
[Target] TCU0003 Bone Curette 5mm Maximus
[Target] TCU0004 Bone Curette 6mm Wang
[Target] TCU0002 Bone Curette 3mm Bishop
[Target] TFP0001 Foraminal Punch 2mm
[Target] TRP0002 Rotational Punch Head 3mm
[Target] TFP0002 Foraminal Punch 3mm
[Target] TRP0001 Rotational Punch Head 2mm
[Target] TVP0001 Viewing portal Retractor straight
[Target] TUV0050 UV Retractor 50mm
[Target] TRR0001 Root Retractor
[Target] TUV0060 UV Retractor 60mm
[Target] TUV0040 UV Retractor 40mm
[Target] TVP0002 Viewing portal Retractor curved
[Target] TMP0002 Micro Pituitary 2mm Up
[Target] TMP0001 Micro Pituitary 2mm Straight
[Target] TIK0001L Indian Knife(Long)
Establishment Types
Repack or Relabel Medical Device