Duns Number:061339651
Device Description: ApeX-LNK Crosslinked Acetabular Insert, UHMWPE 0 degree Hood +4mm Offset, B Insert, 28mm I ApeX-LNK Crosslinked Acetabular Insert, UHMWPE 0 degree Hood +4mm Offset, B Insert, 28mm ID
Catalog Number
H6-13928
Brand Name
OMNI Interface Acetabular System
Version/Model Number
H6-13928
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
-
Product Code
LPH
Product Code Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Public Device Record Key
eb7f099e-cdc2-4147-aa35-80f184d15f20
Public Version Date
September 13, 2021
Public Version Number
3
DI Record Publish Date
November 27, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1365 |