Duns Number:808821883
Device Description: PS TIBIAL INSERT TRIAL SIZE 1 18MM LEFT AND RIGHT
Catalog Number
TPS-030-181S
Brand Name
Identity Imprint Knee Replacement System
Version/Model Number
TPS030181S01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
K210191
Product Code
JWH
Product Code Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Public Device Record Key
9a4c5e36-6ae3-46ae-b41e-be6ee1dab180
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
June 10, 2021
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 | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1451 |