Spinematrix, Inc.
Philedelphia, PA, US
Spinematrix, Inc. appears in FDA device records in Philedelphia, PA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Spinematrix, Inc. in 2011.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1935-2010 | Lumbar Matrix Scan, Diagnostic Electromyography System consisting of the CERSR Electromyography System and Electrode Array; the system consists of two devices. The first is a system of capital equipment referred to as CERSR Electromyography System, which includes a cart. The second device is disposable electrodes arrays, which are single use devices, used with the capital equipment that is adhered to the patient for monitoring the bioelectric signals produced by the muscles. The disposable is referred to as the Electrode Array. CERSR Electromyography System is packaged in a reusable crate maintained by SMI. The Electrode Array is packaged in a sealed foil pouch. Both devices are non-sterile and the packaging is for protection from damage during shipping. | 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, | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain