DEVICE: U2 Total Knee System (04711605575058)
Device Identifier (DI) Information
U2 Total Knee System
2303-1277
In Commercial Distribution
2303-1277
UNITED ORTHOPEDIC CORP.
2303-1277
In Commercial Distribution
2303-1277
UNITED ORTHOPEDIC CORP.
Tibial Insert, Cruciate Retaining, #7, 12mm Thick
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? |
---|---|---|---|---|
33664 | Cruciate-retaining total knee prosthesis |
A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative (e.g., arthritic) joint [total knee arthroplasty (TKA)]; it is designed to be implanted with retention of the posterior cruciate ligament. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE). The device may be implanted with or without bone cement and is typically used in cases where bone stock is good and supporting ligaments provide adequate stability.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150829 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Height: 12 Millimeter |
Device Size Text, specify: #7 |
Device Record Status
008ac4b4-b5a0-4a83-b34e-ccc5ee47faf8
December 21, 2022
5
December 04, 2015
December 21, 2022
5
December 04, 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 |
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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
[?]
+886229294567
service@uoc.com.tw
service@uoc.com.tw