DEVICE: SMR Shoulder (08033390000987)
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Device Identifier (DI) Information
SMR Shoulder
Finned Stem
In Commercial Distribution
1304.15.240
LIMACORPORATE SPA
Finned Stem
In Commercial Distribution
1304.15.240
LIMACORPORATE SPA
Finned humeral stems - 80mm (Ti6Al4V) dia.24mm
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| 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. 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.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K101263 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Dia 24mm |
Device Record Status
365e6c36-269a-4d7e-9f71-6b462d7e4969
November 12, 2019
4
July 29, 2015
November 12, 2019
4
July 29, 2015
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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