DEVICE: MP Reconstruction Prosthesis (04026575325382)

Device Identifier (DI) Information

MP Reconstruction Prosthesis
99-0097/01
In Commercial Distribution
99-0097/01
WALDEMAR LINK GmbH & Co. KG
04026575325382
GS1

1
315675488 *Terms of Use
Neck Segment,with collar, borehole for Saddle Prosthesis
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Uncoated hip femur prosthesis, modular A sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.
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FDA Product Code

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Product Code Product Code Name
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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

89237bfa-65f3-41a7-a6ca-1a91bfccaf80
March 29, 2018
2
November 01, 2015
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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)

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Yes
No
None
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Production Identifier(s) in UDI

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No
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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