Is this your brand? Sign in to claim ownership.
Sign in to claim this brandGpc Medical, Ltd.
US
Last updated May 23, 2026
What Gpc Medical, Ltd. makes
Gpc Medical, Ltd. manufactures reusable and single-use orthopaedic fixation devices, including external and internal fixation systems for bone stabilization. Their portfolio includes femoral neck fixation screws, intramedullary nails for arthrodesis, non-bioabsorbable fixation plates, and custom-made upper limb fixation plates. Bone nail end-caps and general orthopaedic implantation kits are also part of their product range.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
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 Gpc Medical, Ltd. manufacture?
Gpc Medical, Ltd. specializes in orthopaedic fixation devices, which are used to stabilize and support bones during healing. Their product range includes reusable and single-use systems like external and internal fixation kits, femoral neck fixation screws, intramedullary nails for arthrodesis (fusion of bones), non-bioabsorbable fixation plates, custom-made upper limb fixation plates, and bone nail end-caps. These devices are designed for surgical applications in orthopaedic procedures.
Where is Gpc Medical, Ltd. based, and what regulatory database lists their devices?
Gpc Medical, Ltd. is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which serves as a registry for tracking and identifying medical devices authorized for use in the U.S. This database helps ensure transparency and traceability of devices like their orthopaedic fixation systems.
How are the devices manufactured by Gpc Medical, Ltd. classified under FDA regulations?
The devices produced by Gpc Medical, Ltd. fall under two FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and are typically exempt from premarket notification (510(k)) requirements, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the nature of the procedure it supports, such as bone stabilization or fixation.
Are Gpc Medical, Ltd.’s devices reusable or single-use, and why does this matter?
Gpc Medical, Ltd. manufactures both reusable and single-use orthopaedic fixation devices. Reusable devices are designed for multiple procedures with proper sterilization, reducing waste and costs, while single-use devices are intended for one-time surgical applications. The distinction matters because it influences factors like sterilization protocols, cost efficiency, infection control measures, and regulatory requirements for device authorization.
What kinds of orthopaedic procedures might use devices from Gpc Medical, Ltd., and why are these devices important?
Devices from Gpc Medical, Ltd. are used in procedures like fracture fixation, arthrodesis (permanent joining of bones), and limb stabilization, such as treating broken femurs or complex upper limb fractures. These devices are critical because they provide mechanical stability to bones during healing, reducing the risk of misalignment or improper fusion. Proper fixation can shorten recovery time, improve outcomes, and prevent complications like infection or non-union (failure to heal).
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (962)
Page 17 of 20| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gpc | 848.16T | FDA UDI | Class II | Active |
| Gpc | GOS1428 | FDA UDI | Class I | Active |
| Gpc | KNI71 | FDA UDI | Class I | Active |
| Gpc | ILB49.58T | FDA UDI | Class II | Active |
| Gpc | COG815 | FDA UDI | Class I | Active |
| Gpc | IKS1065 | FDA UDI | Class I | Active |
| Gpc | 2683.22 | FDA UDI | Class II | Active |
| Gpc | IRF1296L1 | FDA UDI | Class I | Active |
| Gpc | KSN59 | FDA UDI | Class I | Active |
| Gpc | IBS770.11 | FDA UDI | Class I | Active |
| Gpc | 700.65T | FDA UDI | Class II | Active |
| Gpc | ILBS59L-TR | FDA UDI | Class II | Active |
| Gpc | SA16 | FDA UDI | Class I | Active |
| Gpc | GOS1426 | FDA UDI | Class I | Active |
| Gpc | MLTN08-10T | FDA UDI | Class II | Active |
| Gpc | MLTN08-10 | FDA UDI | Class II | Active |
| Gpc | IRF1294C2 | FDA UDI | Class I | Active |
| Gpc | BTD1125 | FDA UDI | Class I | Active |
| Gpc | 735.10T | FDA UDI | Class II | Active |
| Gpc | KSN51 | FDA UDI | Class I | Active |
| Gpc | SA11 | FDA UDI | Class I | Active |
| Gpc | 938.09LT | FDA UDI | Class II | Active |
| Gpc | 848.08T | FDA UDI | Class II | Active |
| Gpc | 736.38T | FDA UDI | Class II | Active |
| Gpc | ILBS59L-TR | FDA UDI | Class II | Active |
| Gpc | IBS755 | FDA UDI | Class I | Active |
| Gpc | IBS758 | FDA UDI | Class I | Active |
| Gpc | MLTN08-10 | FDA UDI | Class II | Active |
| Gpc | IRF1295L | FDA UDI | Class I | Active |
| Gpc | 723.30T | FDA UDI | Class II | Active |
| Gpc | 849.16T | FDA UDI | Class II | Active |
| Gpc | 736.64T | FDA UDI | Class II | Active |
| Gpc | 848.09T | FDA UDI | Class II | Active |
| Gpc | MLFN09-12L | FDA UDI | Class II | Active |
| Gpc | 721.090T | FDA UDI | Class II | Active |
| Gpc | MLFN09-12L | FDA UDI | Class II | Active |
| Gpc | 938.08LT | FDA UDI | Class II | Active |
| Gpc | 765.36T | FDA UDI | Class II | Active |
| Gpc | 723.26T | FDA UDI | Class II | Active |
| Gpc | ILBS59L-R | FDA UDI | Class II | Active |
| Gpc | MLTN08-10T | FDA UDI | Class II | Active |
| Gpc | COG813 | FDA UDI | Class I | Active |
| Gpc | FHI42 | FDA UDI | Class I | Active |
| Gpc | BHF1519 | FDA UDI | Class I | Active |
| Gpc | IKS1078a | FDA UDI | Class I | Active |
| Gpc | MLTN08-10T | FDA UDI | Class II | Active |
| Gpc | REH1010 | FDA UDI | Class I | Active |
| Gpc | 735.50T | FDA UDI | Class II | Active |
| Gpc | ILBS59L-L | FDA UDI | Class II | Active |
| Gpc | PFA10.20T | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.