FDA Registration
Active
🇰🇷 South Korea
3D Guide Inserter
Reg #: 3005596514
·
FEI: 3005596514
·
Expires 2025
Products
1
Proprietary Names
24
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GS MEDICAL CO., LTD.
- Registration Number
- 3005596514
- FEI Number
- 3005596514
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 90, Osongsaengmyeong 4-ro, Osong-eup,
- City
- Heungdeok-gu, Cheongju-si Chungbuk
- Country
- KR
Owner / Operator
- Firm Name
- GS Solutions, Inc.
- Operator Number
- 9080979
- Address
- 3210 S. Susan St. Santa Ana 92704
- City
- Santa Ana
- State
- CA
- Postal Code
- 92704
- Country
- US
US Agent
- Business Name
- GS SOLUTIONS, INC.
- Contact Name
- James Shin
- Address
- 3210 S Susan St
- City
- Santa Ana
- State
- CA
- ZIP
- 92704
- Country
- US
- [email protected]
- Phone
- 949 3806385 ext. 163
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-02-14 |
Proprietary Names
3D Guide Inserter
Anyplus II Ball Tip Tester, Curved
Scoli I-Ratchet Handle
Trial
OLIF II Tiral
Hex Female
Rod Gripper
Anyplus II Rod Holder
Anyplus II Rod Pusher (Straight Type)
Hex Male
PULSAR Expandable PLIF Navigation Inserter
Hexalobe Male
3D OLIF II Thread Inserter
Anyplus II Pediatric Rod Holder
3D Cervical Cage Trial
Quick Lock
AnyPlus II Persuader
3D Printed OLIF II Trial
Anyplus II Ball Tip Tester, Straight
Navigation Fork Template
Quasar Trial Without Stopper
3D Cervical Cage 3D Printed Trial
Anyplus II Distractor
Anyplus II Tab Breaker
Establishment Types
Manufacture Medical Device