DEVICE: DJO SURGICAL (00888912079709)

Device Identifier (DI) Information

DJO SURGICAL
426-11-100
In Commercial Distribution

Encore Medical, L.P.
00888912079709
GS1

1
154074504 *Terms of Use
HIP, STEM, CLP, LATERAL OFFSET, SIZE#10, IMPLANT, POLISHED NECK
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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].
Active true
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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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K052320 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

d4d9d3cb-9c71-419c-8c2a-8cabc757adfb
April 09, 2020
5
August 07, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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