DEVICE: DJO SURGICAL (00888912143189)

Device Identifier (DI) Information

DJO SURGICAL
500-04-138
In Commercial Distribution

Encore Medical, L.P.
00888912143189
GS1

1
154074504 *Terms of Use
FOUNDATIONĀ® SHOULDER SYSTEM (FS) All-Poly Pegged Glenoid
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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: Ā© Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Total shoulder prosthesis A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.
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FDA Product Code

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Product Code Product Code Name
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K960906 000
No CLOSE

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

322c92f8-a257-48b8-88ee-c8c3f6213c64
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)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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