DEVICE: Uni Femoral Knee (B046WZ110050)

Device Identifier (DI) Information

Uni Femoral Knee
5
In Commercial Distribution
WZ-1-1005
SIGNAL MEDICAL CORPORATION
B046WZ110050
HIBCC

1
169289308 *Terms of Use
Uni Femoral Knee Size 5
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Coated knee femur prosthesis A sterile implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation may be performed with or without bone cement.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K012800 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

d17dd501-1258-499a-be27-7f840535aaea
July 06, 2018
3
August 05, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
8103647070
jgorney@signalmd.com
CLOSE