DEVICE: Glenoid Baseplate with Screw (03701037313336)
Device Identifier (DI) Information
Glenoid Baseplate with Screw
105-4512
In Commercial Distribution
105-4512
FX SOLUTIONS
105-4512
In Commercial Distribution
105-4512
FX SOLUTIONS
CENTRAL SCREW TA6V Ø4.5mm L.12mm
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| 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. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 48094 | Shoulder prosthesis screw |
A sterile screw or set of screws intended for implantable shoulder prosthesis assembly and/or fixation.
|
Obsolete | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K192799 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Store away from light and sunlight Store away from moisture |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
20844537-c4b4-4251-b305-51c701d87849
February 19, 2024
3
June 25, 2020
February 19, 2024
3
June 25, 2020
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