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Sign in to claim this brandCG MedTech Co., Ltd.
South Korea·KR-MF-000035461
Last updated September 17, 2026
What CG MedTech Co., Ltd. makes
CG MedTech Co., Ltd. manufactures spinal fixation hardware, including non-bioabsorbable bone screws, internal spinal fixation systems (with rods and non-sterile components), reusable surgical instruments like instrument trays and bone taps, and polymeric spinal interbody fusion cages. Their portfolio also includes reusable orthopaedic implant drivers and surgical screwdrivers designed for spinal procedures.
The company’s devices are classified as Class I and Class II under regulatory frameworks, with products listed in the FDA’s Unique Device Identifier (UDI) database. CG MedTech Co., Ltd. is based in South Korea.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does CG MedTech Co., Ltd. primarily manufacture?
CG MedTech Co., Ltd. specializes in spinal fixation devices, including non-bioabsorbable bone screws, internal spinal fixation systems (such as rods and non-sterile components), reusable surgical instruments (like instrument trays and bone taps), and polymeric spinal interbody fusion cages. Their product line also covers reusable orthopaedic implant drivers and surgical screwdrivers, all designed for spinal surgical procedures.
Where is CG MedTech Co., Ltd. based, and what does this mean for its regulatory oversight?
CG MedTech Co., Ltd. is based in South Korea. While the country of origin does not directly determine regulatory classification, it influences the regulatory pathways devices must follow for authorization in different markets. For example, devices marketed in the U.S. may need to comply with FDA requirements, while those in the EU would follow MDR or other applicable regulations.
Which regulatory registries or databases list CG MedTech Co., Ltd.’s devices?
CG MedTech Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for regulatory and clinical purposes. Listing in the UDI database is a requirement for Class I and Class II devices in the U.S.
How are CG MedTech Co., Ltd.’s devices classified under regulatory frameworks?
CG MedTech Co., Ltd.’s devices are classified as either Class I or Class II under regulatory systems like the FDA’s classification. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and clinical impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- South Korea
- Address
- 20, Sandan-ro 76beon-gil(Rod), Uijeongbu-si, Gyeonggi-do, South Korea
- Website
- cgmedt.com/
- —
- —
- [email protected]
- Phone
- +82 31 860 6800
- PRRC Contact
- Jae-Hong (James) Kim
- EUDAMED SRN
- KR-MF-000035461
- FDA FEI Number
- 3003200961
- DUNS Number
- 688811082
Catalogue (19097)
Page 47 of 382| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| INNOVERSE Spinal System | NPM5025SD | FDA UDI | Class II | Active |
| INNOVERSE Spinal System | NPA8045PSD | FDA UDI | Class II | Active |
| Perfix™ MIS | SS6100 | FDA UDI | Class II | Active |
| Polarfix™ Facet Screw System | FS0050 | FDA UDI | Class I | Active |
| Dyna Locking Cannulated Screw | TC4001 | FDA UDI | Class I | Active |
| Anax™ 5.5 Spinal System | SFRA7565 | FDA UDI | Class II | Active |
| INNOVERSE Spinal System | NPA9570MLQ | FDA UDI | Class II | Active |
| Anax™ 5.5 Spinal System | SFN7535MC | FDA UDI | Class II | Active |
| Perfix™ MIS | SSS0130 | FDA UDI | Class I | Active |
| Anax™ 5.5 Spinal System | SFNA7560C | FDA UDI | Class II | Active |
| Benefix™ Interspinous Fixation System | IS21234R | FDA UDI | Class II | Active |
| Perfix™ MIS | SS0230 | FDA UDI | Class I | Active |
| Dyna Locking IM Nail | 36002 | FDA UDI | Class II | Active |
| INNOVERSE Spinal System | NP0340 | FDA UDI | Class I | Active |
| Anax™ 5.5 Spinal System | SFN7040MR | FDA UDI | Class II | Active |
| Anax™ 5.5 Spinal System | SF5080CS | FDA UDI | Class II | Active |
| Polarfix™ Facet Screw System | FSA5535 | FDA UDI | U | Active |
| Perfix™ Spinal System | SNA8160 | FDA UDI | Class II | Active |
| Dyna Locking Cannulated Screw™ | 32357 | FDA UDI | Class II | Active |
| Aspiron™ Acp System | NC4012-F | FDA UDI | Class II | Active |
| Anax™ 5.5 Spinal System | SFCA7535 | FDA UDI | Class II | Active |
| Anax™ 5.5 Spinal System | SFNA7040R | FDA UDI | Class II | Active |
| OPTIMA™ ZS Spinal System | SZS1005 | FDA UDI | Class I | Active |
| INNOVERSE Spinal System | NPA7070PRD | FDA UDI | Class II | Active |
| Anax™ 5.5 Spinal System | SFA7550 | FDA UDI | Class II | Active |
| Anax™ 5.5 Spinal System | SFCA6060 | FDA UDI | Class II | Active |
| INNOVERSE Spinal System | NPA5060CRD | FDA UDI | Class II | Active |
| Anax™ 5.5 Spinal System | SFA5055 | FDA UDI | Class II | Active |
| Perfix Deformity Instrument System | SND0440 | FDA UDI | Class I | Active |
| OPTIMA™ ZS Spinal System | SPZ003-F | FDA UDI | Class I | Active |
| INNOVERSE Spinal System | NPA4555PRQ | FDA UDI | Class II | Active |
| Perfix™ Spinal System | SG0006 | FDA UDI | Class I | Active |
| Anax™ 5.5 Spinal System | SFNA7580C | FDA UDI | Class II | Active |
| Aspiron™ S Acpsystem | FCA2041 | FDA UDI | Class II | Active |
| Anax™ 5.5 Spinal System | SFNA7550CR | FDA UDI | Class II | Active |
| Perfix™ Spinal System | SN0008 | FDA UDI | Class I | Active |
| Anax™ 5.5 Spinal System | SFMCR7055 | FDA UDI | Class II | Active |
| Anax™ 5.5 Spinal System | SFCRA7560 | FDA UDI | Class II | Active |
| Benefix™ Interspinous Fixation System | IS21247R | FDA UDI | Class II | Active |
| Anax™ 5.5 Spinal System | SFRA6080 | FDA UDI | Class II | Active |
| General Handle | PE0911 | FDA UDI | Class I | Active |
| Perfix™ Spinal System | SN1055C | FDA UDI | Class I | Active |
| Spinal Hook System™ | SH0709-A8 | FDA UDI | Class II | Active |
| INNOVERSE Spinal System | NPA8545PSQ | FDA UDI | Class II | Active |
| Velofix™ SA Cervical Cage | TS3511FD | FDA UDI | Class II | Active |
| Dyna Locking IM Nail | IN1029 | FDA UDI | Class I | Active |
| Velofix™ SA Cervical Cage | TSA6405 | FDA UDI | Class II | Active |
| Anax™ 5.5 Spinal System | SFA6075 | FDA UDI | Class II | Active |
| INNOVERSE Spinal System | NPA9025MLQ | FDA UDI | Class II | Active |
| INNOVERSE Spinal System | NPA7035PSQ | FDA UDI | Class II | Active |
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