Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented or Uncemented
Which Manufacturers in China Make This?
2 manufacturers in China hold an FDA registration for this device type, based in Jiangsu and Shanghai.
- Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Jiangsu
- Shanghai JPY ION-Tech Co., Ltd. Shanghai, contract manufacturer
How Is MRA Classified?
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented is FDA product code MRA, Class 3.
What Does It Take to Sell It in the United States?
A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.
What Do the Recalls Say?
The FDA has recorded 23 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Employee error (6), Packaging process control (6) and Process control (2).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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