Duns Number:295437313
Device Description: Offset Reamer Handle (Stryker Z/H – Dual Reamer Coupling (NC))
Catalog Number
50244525
Brand Name
Trinity Acetabular Hip System
Version/Model Number
50244525
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
-
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
K093472
Product Code
LWJ
Product Code Name
Prosthesis, hip, semi-constrained, metal/polymer, uncemented
Public Device Record Key
151ae3dc-d441-4c2b-aac7-23bd6e87b9c7
Public Version Date
September 21, 2018
Public Version Number
1
DI Record Publish Date
August 21, 2018
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. | 3697 |
| 3 | A medical device with high risk that requires premarket approval | 21 |