Duns Number:373139427
Device Description: MRI Zimmer Guide and Bone Model for Partial Knee Arthroplasty
Catalog Number
KNM-ZB13-00-01
Brand Name
Zimmer Biomet Patient Specific Instruments
Version/Model Number
KNM-ZB13-00-01
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
K173970,K202207
Product Code
HSX
Product Code Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Public Device Record Key
3782e62d-a9f5-4214-8a91-25076c03682d
Public Version Date
January 19, 2021
Public Version Number
3
DI Record Publish Date
August 11, 2018
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 | 91 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 296 |