Duns Number:116995646
Device Description: Tapered Femoral Stem, Extended-Lateral Offset 10.5mm
Catalog Number
1401-922-105
Brand Name
Kyocera Medical Technologies, Inc.
Version/Model Number
A 400
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
K171543
Product Code
LPH
Product Code Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Public Device Record Key
acf78db4-47d6-440c-a1d2-b4f0aaf7c4e0
Public Version Date
July 29, 2019
Public Version Number
3
DI Record Publish Date
January 17, 2019
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 |