Duns Number:432066322
Device Description: PHYSICA LMC (cross-linked UHMWPE with Vitamin E) - Tibial Liner # 9 H. 12 mm Left
Catalog Number
6537.54.912
Brand Name
PHYSICA LMC
Version/Model Number
6537.54.912
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
K201084
Product Code
HRY
Product Code Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Public Device Record Key
72c94fb5-c752-49f5-9aa6-adfb9d8536a5
Public Version Date
January 01, 2021
Public Version Number
1
DI Record Publish Date
December 24, 2020
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 | 595 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3634 |