Transtibial Anterior Cruciate Ligament Kit
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Zhejiang.
- GRI Medical & Electronic Technology Co., Ltd. Zhejiang, contract manufacturer
What Is It?
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
What Is FDA Product Code PPQ?
Transtibial Anterior Cruciate Ligament Kit is FDA product code PPQ, Class 2, 21 CFR 888.3040.
How Does It Reach the US Market?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.