DEVICE: SOLAR (07613327135992)
Device Identifier (DI) Information
SOLAR
6948-0-508
In Commercial Distribution
6948-0-508
Howmedica Osteonics Corp.
6948-0-508
In Commercial Distribution
6948-0-508
Howmedica Osteonics Corp.
Radial Head Prosthesis
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Elbow radius prosthesis | A sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] or metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWI | PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K001385 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Size: SM |
Device Size Text, specify: Thickness: 8.0 Millimeter |
Device Record Status
f8ba0e01-468d-4753-bb64-b4e191d92757
July 06, 2018
3
September 24, 2015
July 06, 2018
3
September 24, 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 |
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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