DEVICE: DJO SURGICAL (00888912076753)
Device Identifier (DI) Information
DJO SURGICAL
411-00-140
In Commercial Distribution
Encore Medical, L.P.
411-00-140
In Commercial Distribution
Encore Medical, L.P.
HEAD, UNIPOLAR, MODULAR, ENCORE SIZE40
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? |
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33175 | Metallic femoral head prosthesis |
An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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KWL | Prosthesis, Hip, Hemi-, Femoral, Metal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K973614 | 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
2b7ab3f1-6301-43cc-9ce3-ab89478c8d2d
April 06, 2020
6
August 07, 2017
April 06, 2020
6
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