Question 1

What types of medical devices does Gpc Medical, Ltd. manufacture?

Accepted Answer

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.

Question 2

Where is Gpc Medical, Ltd. based, and what regulatory database lists their devices?

Accepted Answer

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.

Question 3

How are the devices manufactured by Gpc Medical, Ltd. classified under FDA regulations?

Accepted Answer

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.

Question 4

Are Gpc Medical, Ltd.’s devices reusable or single-use, and why does this matter?

Accepted Answer

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.

Question 5

What kinds of orthopaedic procedures might use devices from Gpc Medical, Ltd., and why are these devices important?

Accepted Answer

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).

Device	Model / Reference	Registries	Class	Status
Gpc	BTD1130	FDA UDI	Class I	Active
Gpc	KSN56	FDA UDI	Class I	Active
Gpc	906.12TL	FDA UDI	Class II	Active
Gpc	745.80T	FDA UDI	Class II	Active
Gpc	724.16T	FDA UDI	Class II	Active
Gpc	IBS758	FDA UDI	Class I	Active
Gpc	700.42T	FDA UDI	Class II	Active
Gpc	ILBS59L-TR	FDA UDI	Class II	Active
Gpc	9009	FDA UDI	Class I	Active
Gpc	S-IBP630	FDA UDI	Class I	Active
Gpc Bone Plaes And Bone Screw & Gpc Dhs/Dcs Plate System	K092493	FDA 510(k)	Class II	Active
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.	K153716	FDA 510(k)	Class II	Active

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