DEVICE: DJO SURGICAL (00888912116145)

Device Identifier (DI) Information

DJO SURGICAL
340-45-009
In Commercial Distribution

Encore Medical, L.P.
00888912116145
GS1

1
154074504 *Terms of Use
EPIK® KNEE SYSTEM CM Onlay Tibia Insert
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Unicondylar knee prosthesis A sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.
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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 [?]
K020741 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

f725f932-0027-46d2-a50a-2b9cb1890baa
July 06, 2018
3
August 07, 2017
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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
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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