DEVICE: Unity Total Knee System (05055343891537)

Device Identifier (DI) Information

Unity Total Knee System
123.081.00
In Commercial Distribution
123.081.00
CORIN LTD
05055343891537
GS1

1
295437313 *Terms of Use
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

[?]

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?
46480 Orthopaedic knee-balance analyser, non-electrical
A mechanical orthopaedic device intended for measurement of the forces within the knee joint during a total knee arthroplasty (TKA) to assist with further planning of the procedure. It is typically a spring-loaded device with paddles to push against the adjacent joint surfaces and scales to display a force reading. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K113060 000
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Sterilization

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

[?]
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 Record Status

ec397f3b-fce1-403e-984d-a5db2878c1e9
August 05, 2022
4
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

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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