Duns Number:079674160
Device Description: OrthoGrid Hip 3.0 for non-invasive software system that provides image analysis tools for OrthoGrid Hip 3.0 for non-invasive software system that provides image analysis tools for Total Hip Replacement
Catalog Number
-
Brand Name
OrthoGrid Hip
Version/Model Number
1015-915-504
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
K210136
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
8fadce9a-afbb-43d4-abee-1b454a8f0fe7
Public Version Date
March 15, 2021
Public Version Number
1
DI Record Publish Date
March 05, 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 |