DEVICE: OsteoBridge™ IKA Knee Arthrodesis Nail (04048266078872)
Device Identifier (DI) Information
OsteoBridge™ IKA Knee Arthrodesis Nail
with Collar 16 130
In Commercial Distribution
GA11613
Merete GmbH
with Collar 16 130
In Commercial Distribution
GA11613
Merete GmbH
TiAl6V4 ELI sterile
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
58085 | Knee arthrodesis prosthesis |
A fused (non-articulating) replacement for the knee joint intended to be implanted after failed primary knee arthroplasty and which functions as a bridge between the resected metaphyses of the femur and tibia. It is a modular device that typically includes resection elements (spacers), intramedullary nails (inserted into the intramedullary canal), screws, and connectors all made of metal [e.g., titanium (Ti)]; components are both sterile and non-sterile. Instruments for implantation are typically included and implantation may be performed with or without bone cement.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HSB | Rod, Fixation, Intramedullary And Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K101939 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 130 Millimeter |
Outer Diameter: 16 Millimeter |
Device Record Status
4c2b8d4e-ca8b-458d-9f43-9859299f5989
May 12, 2023
7
October 15, 2015
May 12, 2023
7
October 15, 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(630)869-1092
service@merete-medical.com
service@merete-medical.com