DEVICE: Unity Total Knee System (05055343891537)

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Device Identifier (DI) Information

Unity Total Knee System
123.081.00
123.081.00
CORIN LTD
05055343891537
GS1
1
Ligament Balancer Extension Attachment
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Orthopaedic knee-balance analyser A mechanical orthopaedic measuring/testing instrument used by a surgeon during the procedure to interrogate the strength and integrity of the ligaments that support (balance) the knee, prior to bony resection for a total knee arthroplasty (TKA). This may provide information essential to the selection of an optimal type of knee prosthesis. It is typically a spring-loaded device with dual-force scales that uses integral paddles to push against the rejected tibia and unresected femoral condyles. The surgeon can increase the force applied and obtain readings from the scales. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 17, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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+441285659866 2118
rachel.king@coringroup.com
+441285659866 2203
lucinda.gerber@coringroup.com
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