Duns Number:745735175
Device Description: Patient Specific Acetabular Guide ,Trial Acetabulum,Patient Specific Femoral Guide and Tri Patient Specific Acetabular Guide ,Trial Acetabulum,Patient Specific Femoral Guide and Trial Femoral Head
Catalog Number
-
Brand Name
Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral
Version/Model Number
1248-1500, 1248-1700, 1250-1100,1250-1200
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
K152893,K181061
Product Code
LWJ
Product Code Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Public Device Record Key
5198be01-ffed-4618-9eef-1aeffb302fa8
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
April 18, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |