Duns Number:079674160
Device Description: OrthoGrid Trauma for non-invasive software system that provides image analysis tools for t OrthoGrid Trauma for non-invasive software system that provides image analysis tools for trauma procedures
Catalog Number
-
Brand Name
OrthoGrid Hip Trauma
Version/Model Number
2010-915-502
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"
-
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
K192279
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
b1e28b5d-5440-4123-9606-852d8e1cb650
Public Version Date
September 06, 2021
Public Version Number
1
DI Record Publish Date
August 27, 2021
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |