Duns Number:488227125
Device Description: E-CROSS tibial insert fix S8 RM - 14mm
Catalog Number
-
Brand Name
MOTO Partial Knee System
Version/Model Number
02.18.EIF8.14.RM
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
Yes
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
K213071
Product Code
HSX
Product Code Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Public Device Record Key
5f67244f-c045-49e5-8e3e-20c392247871
Public Version Date
November 26, 2021
Public Version Number
1
DI Record Publish Date
November 18, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8200 |
2 | A medical device with a moderate to high risk that requires special controls. | 9084 |