DEVICE: PRIMA TT Glenoid (08033390248587)

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Device Record History
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Device Identifier (DI) Information
PRIMA TT Glenoid
1974.54.440
In Commercial Distribution
1974.54.440
LIMACORPORATE SPA
08033390248587
GS1

1
432066322 *Terms of Use
PRIMA TT Glenoid - Glenosphere with Screw Dia. 44; Low Lateralization (5mm)
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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?
48093 Reverse shoulder prosthesis head
A sterile component of a reverse shoulder prosthesis that consists of a hemisphere-shaped metal or combined metal/polyethylene piece (glenosphere) intended to be attached to the reverse shoulder base plate, or directly to the glenoid fossa of the scapula, to articulate with the reverse shoulder cup.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
PHX Shoulder Prosthesis, Reverse Configuration
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K252352 000
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Dia. 44; Low Lateralization (5mm)
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Device Record Status
b13b36ce-a5f2-49bf-8e81-7227db4c9f10
February 27, 2026
1
February 19, 2026
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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

[?]
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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