Duns Number:116995646
Device Description: Porous Acetabular Cup System - Hemispherical Shell Cluster Hole 52 mm Diameter
Catalog Number
1501-141-052
Brand Name
Kyocera Medical Technologies, Inc.
Version/Model Number
A 450
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
K141676
Product Code
LPH
Product Code Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Public Device Record Key
5329536b-5834-4611-8853-64d3b3316697
Public Version Date
September 09, 2020
Public Version Number
6
DI Record Publish Date
October 29, 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 |