LINK Embrace Shoulder System Line Extension 645-081/05

GUDID 04026575533770

Glenoid baseplate, uncemented, Ti6Al4V-3D-printed, standard, reverse

WALDEMAR LINK GmbH & Co. KG

Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate

• Primary Device ID: 04026575533770
• NIH Device Record Key: 9984d84a-5f3c-4ef5-bdec-3a8a56d9d8a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LINK Embrace Shoulder System Line Extension
• Version Model Number: 645-081/05
• Catalog Number: 645-081/05
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026575533770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231445

FDA Product Code

• PAO: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-30
• Device Publish Date: 2024-01-22

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• 04026575533770: Glenoid baseplate, uncemented, Ti6Al4V-3D-printed, standard, reverse
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• 04026575533732: Glenoid baseplate, uncemented, Ti6Al4V-3D-printed, standard, reverse
• 04026575533725: Glenoid baseplate, uncemented, Ti6Al4V-3D-printed, standard, reverse
• 04026575533718: Glenoid baseplate, uncemented, Ti6Al4V-3D-printed, wedged, reverse
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• 04026575533411: Glenosphere, uncemented, CoCrMo, lateralized, reverse