DEVICE: DJO SURGICAL (00888912079723)
Device Identifier (DI) Information
DJO SURGICAL
426-11-120
In Commercial Distribution
Encore Medical, L.P.
426-11-120
In Commercial Distribution
Encore Medical, L.P.
HIP, STEM, CLP, LATERAL OFFSET, SIZE#12, IMPLANT, POLISHED NECK
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
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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38155 | Press-fit femoral stem prosthesis |
A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWL | Prosthesis, Hip, Hemi-, Femoral, Metal |
KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K052320 | 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
4ee579f1-0087-46b0-a37a-300becc25a68
April 09, 2020
5
August 07, 2017
April 09, 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