DEVICE: ENDURO (04046963165611)
Device Identifier (DI) Information
ENDURO
NB025K
Not in Commercial Distribution
NB025K
Aesculap AG
NB025K
Not in Commercial Distribution
NB025K
Aesculap AG
ENDURO TIBIA HEMI-WEDGE T1 4MM RM/LL
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
48067 | Knee arthroplasty wedge |
An implantable device designed to augment the implantation of a knee femur or tibia prosthesis by serving as a space-filler adjacent to the prosthesis, typically to replace lost bone and increase bone contact area and aid stability. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KRO | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Figure / Size : T1 |
Device Size Text, specify: Implant Fixation : cemented |
Device Size Text, specify: Height : 4.000 MM |
Device Size Text, specify: Anatomic Term : right medial / left lateral |
Device Record Status
f3534bd2-8bea-4fca-a17b-9ef0ef57d642
February 03, 2023
6
September 24, 2015
February 03, 2023
6
September 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(888)229-3002
setworld_orders@aesculap.com
setworld_orders@aesculap.com