DEVICE: DJO SURGICAL (00888912143561)
Device Identifier (DI) Information
DJO SURGICAL
503-46-022
In Commercial Distribution
Encore Medical, L.P.
503-46-022
In Commercial Distribution
Encore Medical, L.P.
HEAD, HUMERAL W/FEMALE TAPER, 46X22
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
35670 | 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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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K950651 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e40229d9-ef75-4ac4-b201-b4ad3d08aa4b
April 27, 2020
5
August 07, 2017
April 27, 2020
5
August 07, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined