Spinematrix, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Spinematrix, Inc. makes
Spinematrix, Inc. manufactures the CERSR Electromyography (EMG) System, a device designed for assessing and monitoring muscle and nerve function through electromyographic testing.
The company’s portfolio is regulated under FDA’s Class II device classification and is listed via the 510(k) premarket notification process. The manufacturer is based in the United States.
Catalogue
Cersr Electromyography System Ref K110048
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Spinematrix, Inc., initiated on 2010-01-29. 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.
2010
- 29 Jan 2010 Z-1935-2010 Unclassified (pre-2012) Terminated A full design review of the CERSR system was conducted in 7/2009. The audit revealed numerous design verification tests that either did not pass or did not meet the design input requirement. One requirement found that it was possible for the physician to think they were reviewing one patients scan, but were actually reviewing a scan from a different patient. This event did not happen; however,
Frequently asked questions
How many devices does Spinematrix, Inc. have in the registry?
The registry currently lists 1 device for Spinematrix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spinematrix, Inc.'s devices?
Among its 1 most recently registered device, Spinematrix, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Spinematrix, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Spinematrix, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Spinematrix, Inc.?
FDA recall records list 1 recall initiated by Spinematrix, Inc., the most recent initiated on 29 Jan 2010. 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 Spinematrix, Inc. in the registry?
The most recently registered devices listed for Spinematrix, Inc. include CERSR ELECTROMYOGRAPHY SYSTEM.