Duns Number:116995646
Device Description: Bipolar Implant 60mm OD - 28mm ID
Catalog Number
1416-028-060
Brand Name
Kyocera Medical Technologies, Inc.
Version/Model Number
Bipolar Hip
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
K131354
Product Code
KWY
Product Code Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Public Device Record Key
2023a83c-1c40-42fc-b1d3-c86fc6fc1463
Public Version Date
September 09, 2020
Public Version Number
6
DI Record Publish Date
October 28, 2015
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 | 2246 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3237 |