Duns Number:081840873
Device Description: The SpinaLogic is a portable, battery powered, microcontrolled, noninvasive bone growth st The SpinaLogic is a portable, battery powered, microcontrolled, noninvasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The SpinaLogic is available in one size.
Catalog Number
01-207-0007
Brand Name
CMF
Version/Model Number
Spinalogic
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LOF
Product Code Name
Stimulator, Bone Growth, Non-Invasive
Public Device Record Key
880c2eac-4320-460c-b0c1-f54f51c2f862
Public Version Date
July 29, 2019
Public Version Number
3
DI Record Publish Date
September 22, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 784 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1030 |
| 3 | A medical device with high risk that requires premarket approval | 8 |