DEVICE: Uniglide Unicondylar Knee Prosthesis (05055196907942)
Device Identifier (DI) Information
Uniglide Unicondylar Knee Prosthesis
BC8K-1R00-001
In Commercial Distribution
BC8K-1R00-001
CORIN LTD
BC8K-1R00-001
In Commercial Distribution
BC8K-1R00-001
CORIN LTD
TIBIAL RESECTION Block RIGHT +2
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47815 | Orthopaedic implant aiming/guiding block, reusable |
A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K050764 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ff5ef24a-633a-4773-9c7c-3987697fb774
July 06, 2018
3
August 17, 2016
July 06, 2018
3
August 17, 2016
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
[?]
+441285659866
2203
lucinda.gerber@coringroup.com +441285659866 2118
rachel.king@coringroup.com
lucinda.gerber@coringroup.com +441285659866 2118
rachel.king@coringroup.com