DEVICE: LINK Embrace Shoulder System Line Extension (04026575534746)

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Device Record History
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Device Identifier (DI) Information
LINK Embrace Shoulder System Line Extension
645-081/59
In Commercial Distribution

WALDEMAR LINK GmbH & Co. KG
04026575534746
GS1

1
315675488 *Terms of Use
Orthopaedic implant impactor - LINK Embrace Shoulder System
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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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?
32856 Orthopaedic implant impactor, reusable
A non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
PHX Shoulder Prosthesis, Reverse Configuration
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K231445 000
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
821ccdd1-37de-48bd-8212-861640ff48d0
February 09, 2026
2
July 11, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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