Lifenet
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Lifenet makes
Lifenet manufactures bone graft materials, including OPTIUM DBM Gel and Putty, designed for spinal and orthopedic applications to support bone regeneration and fusion procedures.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Optium Dbm Gel And Putty Ref K053098
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Lifenet, initiated on 2002-12-19. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2002
- 19 Dec 2002 Z-0525-03 Unclassified (pre-2012) Terminated Recalling firm distributed a heart valve from donor whose sera was found potentially positive for Hepatitis C.
Frequently asked questions
How many devices does Lifenet have in the registry?
The registry currently lists 1 device for Lifenet. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lifenet's devices?
Among its 1 most recently registered device, Lifenet has devices listed in FDA 510(k) (1 device).
What risk classes do Lifenet's devices fall under?
Among its 1 most recently registered device, the classes recorded for Lifenet's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Lifenet?
FDA recall records list 1 recall initiated by Lifenet, the most recent initiated on 19 Dec 2002. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Lifenet in the registry?
The most recently registered devices listed for Lifenet include OPTIUM DBM GEL AND PUTTY.