Duns Number:080101891
Device Description: H2 TIBIAL TRAY SIZE 4 - RIGHT (7MM)
Catalog Number
421804
Brand Name
Hintermann Series H2
Version/Model Number
1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171004
Product Code
HSN
Product Code Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Public Device Record Key
41d08b51-db05-4748-9fdd-fd2b58403a7d
Public Version Date
October 16, 2020
Public Version Number
4
DI Record Publish Date
March 20, 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 | 110 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 52 |