Duns Number:034442726
Device Description: Tryon Acetabular Cup Liner, 10° Hood/Lipped, 28mm Head, SIZE 28/48-50mm XL - UHMWPE, Cross Tryon Acetabular Cup Liner, 10° Hood/Lipped, 28mm Head, SIZE 28/48-50mm XL - UHMWPE, Cross-Linked
Catalog Number
AL2-28-248
Brand Name
OrthoMedFlex
Version/Model Number
AL2-28-248
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LPH
Product Code Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Public Device Record Key
4acf7662-9833-4f49-beb7-c7d9d29d2ca3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 13, 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 | 371 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 435 |