Riva Posterior Fixation System
BONE SCREW, CANNULATED, CORTICAL CANCELLOUS, 11.5mm X 65mm
Guidewire, Catheter, Reprocessed
Which Manufacturers in China Make This?
2 manufacturers in China hold an FDA registration for this device type, based in Jiangsu and Tianjin.
- Steris Sterilization Technologies (Suzhou) Ltd Jiangsu, contract manufacturer
- Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. Tianjin, contract manufacturer
What Is This Device?
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
How Is NKQ Classified?
Guidewire, Catheter, Reprocessed is FDA product code NKQ, Class 2, 21 CFR 870.1330.
What Does It Take to Sell It in the United States?
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.
What Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2021. None was by a company in China. 1 is Class I, the most serious grade.
The root cause the FDA records most often is Component design/selection (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Name
Record