Narang Medical , Ltd.
India IN-MF-000018817 Last updated 22 Oct 2026 Part of Narang Medical Limited
- Devices
- 110
- Registries
- EUDAMEDFDA 510(k)
- FDA recalls
- 0
Catalogue
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NET BRAND Osteosynthesis Nailing System Ref K233150
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What Narang Medical , Ltd. makes
Narang Medical, Ltd. manufactures the NET BRAND Osteosynthesis Nailing System, a device used for internal fixation of long bone fractures, including those of the femur and tibia.
The company’s portfolio is regulated under FDA’s Class II designation and requires 510(k) clearance. The device is listed in the FDA’s 510(k) registry. Narang Medical, Ltd. is based in the United States.
Frequently asked questions
What types of medical devices does Narang Medical, Ltd. manufacture?
Narang Medical, Ltd. specializes in orthopedic devices, specifically the NET BRAND Osteosynthesis Nailing System. This system is designed for internal fixation of long bone fractures, such as those in the femur or tibia, helping stabilize and support bone healing during recovery.
Where is Narang Medical, Ltd. based, and how does this affect its regulatory oversight?
Narang Medical, Ltd. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The NET BRAND Osteosynthesis Nailing System falls under FDA’s Class II classification, which requires pre-market notification (510(k)) clearance before commercial distribution.
Which regulatory registries list Narang Medical, Ltd.’s devices, and why is this important?
The NET BRAND Osteosynthesis Nailing System is listed in the FDA’s 510(k) registry. This registry serves as a public record of devices that have undergone the required pre-market clearance process, demonstrating compliance with FDA standards before they enter the market. Listing in this registry helps ensure transparency and verifies that the device meets regulatory requirements.
How are Narang Medical, Ltd.’s devices classified by regulatory authorities, and what does this mean?
The NET BRAND Osteosynthesis Nailing System is classified as a Class II device by the FDA. This classification indicates moderate risk and requires manufacturers to submit a 510(k) premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device. Class II devices undergo additional controls beyond general controls to ensure safety and effectiveness.
Information
- Country
- India
- Address
- Narang Tower, New Delhi, India
- Website
- www.narang.com
- [email protected]
- PRRC contact
- Vivek Narang
- EUDAMED SRN
- IN-MF-000018817