Hohenstein Enterprises, Inc.
Country not established
- Devices
- 1
What Hohenstein Enterprises, Inc. makes
Hohenstein Enterprises, Inc. manufactures porous high-density polyethylene (HDPE) surgical implants, marketed under trademarks such as EPOR, Biopor, Minopor, and P-HDPE. These devices are designed for internal medical use and are intended to integrate with biological tissue.
The company’s porous HDPE implants are classified as Class II devices under FDA regulations and are recorded in the FDA’s 510(k) clearance database. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hohenstein Enterprises, Inc. have in the registry?
The registry currently lists 1 device for Hohenstein Enterprises, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hohenstein Enterprises, Inc.'s devices?
Among its 1 most recently registered device, Hohenstein Enterprises, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Hohenstein Enterprises, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Hohenstein Enterprises, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hohenstein Enterprises, Inc. in the registry?
The most recently registered devices listed for Hohenstein Enterprises, Inc. include POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE.