DEVICE: Uni Tibial Insert (B046WZ110340)

Device Identifier (DI) Information

Uni Tibial Insert
4x12
In Commercial Distribution
WZ-1-1034
SIGNAL MEDICAL CORPORATION
B046WZ110340
HIBCC

1
169289308 *Terms of Use
Uni Tibial Insert 4x12
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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
Tibial insert An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.
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FDA Product Code

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Product Code Product Code Name
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K012800 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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 Record Status

8bb1f3c3-680e-46ae-8e63-22bab3db986c
July 06, 2018
3
March 25, 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)

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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
810-364-7070
jgorney@signalmd.com
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