Duns Number:634855407
Device Description: ANATOMIC® Tibial Base Plate for Fixed Bearing Insert Cemented Size 8
Catalog Number
1-0209908
Brand Name
ANATOMIC
Version/Model Number
1-0209908
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"
Yes
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
K161414
Product Code
JWH
Product Code Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Public Device Record Key
e136c901-269a-4dd5-a0ab-835f91de6ba2
Public Version Date
December 11, 2019
Public Version Number
4
DI Record Publish Date
August 08, 2017
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. | 499 |