Duns Number:263076196
Device Description: Humelock II Cementless Shoulder System PRCT II HUMERAL PLATE TA6V LEFT 5 HOLES
Catalog Number
311-0209
Brand Name
FX Solutions
Version/Model Number
SIZE 09 CEMENTLESS PRCT2
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K143721
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
bb538d7a-2b6d-4b5a-97b6-e6c13ee239bb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 09, 2016
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 | 663 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 478 |