bioBLOCK® Subtalar Implant System
The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding…
Prosthesis, Subtalar, Plug, Polymer
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Kingj Medical Co., Ltd. Jiangsu, contract manufacturer
How Is MJW Classified?
Prosthesis, Subtalar, Plug, Polymer is FDA product code MJW, Class 2, 21 CFR 888.3040.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.