DEVICE: SMR Shoulder (08033390155502)
Device Identifier (DI) Information
SMR Shoulder
1304.15.025
In Commercial Distribution
1304.15.025
LIMACORPORATE SPA
1304.15.025
In Commercial Distribution
1304.15.025
LIMACORPORATE SPA
Finned Stem SHORT Dia. 25 mm
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? |
---|---|---|---|---|
48090 | Press-fit shoulder humeral stem prosthesis |
A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural humerus to achieve a mechanical interlock without the use of bone cement.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
PHX | Shoulder Prosthesis, Reverse Configuration |
KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K191963 | 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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Device Size Text, specify: SHORT Dia. 25 mm |
Device Record Status
ca30d34d-260b-4efe-9eca-cc3d01342d1d
November 18, 2019
1
November 09, 2019
November 18, 2019
1
November 09, 2019
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
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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