DEVICE: Glenoid Baseplate with Screw (03701037313336)

Device Identifier (DI) Information

Glenoid Baseplate with Screw
105-4512
In Commercial Distribution
105-4512
FX SOLUTIONS
03701037313336
GS1

1
263076196 *Terms of Use
CENTRAL SCREW TA6V Ø4.5mm L.12mm
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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
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FDA Product Code

[?]
Product Code Product Code Name
PHX Shoulder Prosthesis, Reverse Configuration
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K192799 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store away from light and sunlight Store away from moisture
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

20844537-c4b4-4251-b305-51c701d87849
February 19, 2024
3
June 25, 2020
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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
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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