Duns Number:488227125
Device Description: Masterloc Cementless Ti Coated STD Stem # 5
Catalog Number
-
Brand Name
Masterloc Femoral Stems
Version/Model Number
01.39.005
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
K151531
Product Code
KWY
Product Code Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Public Device Record Key
68318f2c-a8ac-4eba-8459-2b00457a2e5f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 04, 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 | 8200 |
2 | A medical device with a moderate to high risk that requires special controls. | 9084 |