Trabecular Metal™
2 catalogue numbers from 00-5451-013-68, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Instrument, Cranioplasty Material Forming. 1 manufacturer in China is registered for this product code.
Instrument, Cranioplasty Material Forming
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.
- Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Jiangsu, contract manufacturer
How Is HBX Classified?
Instrument, Cranioplasty Material Forming is FDA product code HBX, Class 1, 21 CFR 882.4500.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
What Do the Recalls Say?
The FDA has recorded 3 recalls under this product code since 2010. None was by a company in China. The root cause the FDA records most often is Packaging process control (3).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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