Duns Number:042961576
Device Description: Total Ankle, Instrument, Poly Trial Insert, Size 4, 15MM, 3.75MM ANT/POST Offset, PPSU
Catalog Number
P10-931-I415
Brand Name
APEX 3D Total Ankle Replacement System
Version/Model Number
P10-931-I415
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
-
Product Code
HSN
Product Code Name
PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Public Device Record Key
ea621f7e-08a8-49fa-b065-01f59844538c
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 14, 2022
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 | 1122 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3564 |