LINK Embrace Shoulder System Line Extension

GUDID 04026575534814

Shoulder glenoid fossa prosthesis trial - LINK Embrace Shoulder System

WALDEMAR LINK GmbH & Co. KG

Shoulder glenoid fossa prosthesis trial
Primary Device ID04026575534814
NIH Device Record Key32b4de32-4d2a-4794-bd88-a63bfb5a86d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameLINK Embrace Shoulder System Line Extension
Version Model Number646-642/03
Company DUNS315675488
Company NameWALDEMAR LINK GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104026575534814 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04026575534814]

Moist Heat or Steam Sterilization


[04026575534814]

Moist Heat or Steam Sterilization


[04026575534814]

Moist Heat or Steam Sterilization


[04026575534814]

Moist Heat or Steam Sterilization


[04026575534814]

Moist Heat or Steam Sterilization


[04026575534814]

Moist Heat or Steam Sterilization


[04026575534814]

Moist Heat or Steam Sterilization


[04026575534814]

Moist Heat or Steam Sterilization


[04026575534814]

Moist Heat or Steam Sterilization


[04026575534814]

Moist Heat or Steam Sterilization


[04026575534814]

Moist Heat or Steam Sterilization


[04026575534814]

Moist Heat or Steam Sterilization


[04026575534814]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-22
Device Publish Date2024-07-12

On-Brand Devices [LINK Embrace Shoulder System Line Extension]

04026575533398Glenosphere, uncemented, CoCrMo, lateralized, reverse
04026575533404Glenosphere, uncemented, CoCrMo, lateralized, reverse
04026575533787Glenoid baseplate, uncemented, Ti6Al4V-3D-printed, wedged, reverse
04026575533770Glenoid baseplate, uncemented, Ti6Al4V-3D-printed, standard, reverse
04026575533763Glenoid baseplate, uncemented, Ti6Al4V-3D-printed, wedged, reverse
04026575533756Glenoid baseplate, uncemented, Ti6Al4V-3D-printed, lateralized, reverse
04026575533749Glenoid baseplate, uncemented, Ti6Al4V-3D-printed, lateralized, reverse
04026575533732Glenoid baseplate, uncemented, Ti6Al4V-3D-printed, standard, reverse
04026575533725Glenoid baseplate, uncemented, Ti6Al4V-3D-printed, standard, reverse
04026575533718Glenoid baseplate, uncemented, Ti6Al4V-3D-printed, wedged, reverse
04026575533657Reverse tray, uncemented, CoCrMo, extended
04026575533442Glenosphere, uncemented, CoCrMo, lateralized, reverse
04026575533435Glenosphere, uncemented, CoCrMo, lateralized, reverse
04026575533428Glenosphere, uncemented, CoCrMo, lateralized, reverse
04026575533411Glenosphere, uncemented, CoCrMo, lateralized, reverse
04026575533640Bone Screws, and Cortical Bone Screw
04026575533633Bone Screws, and Cortical Bone Screw
04026575533626Bone Screws, and Cortical Bone Screw
04026575533619Bone Screws, and Cortical Bone Screw
04026575533602Bone Screws, and Cortical Bone Screw
04026575533596Bone Screws, and Cortical Bone Screw
04026575533589Bone Screws, and Cortical Bone Screw
04026575533572Bone Screws, and Cancellous Bone Screw
04026575533565Bone Screws, and Cancellous Bone Screw
04026575533558Bone Screws, and Cancellous Bone Screw
04026575533541Bone Screw, and Cancellous Bone Screw
04026575533534Bone Screws, and Cancellous Bone Screw
04026575533527Bone Screws, and Cancellous Bone Screw
04026575533510Bone Screws, and Cancellous Bone Screw
04026575439577Bone Screws, and Cortical Bone Screw
04026575439560Bone Screws, and Cortical Bone Screw
04026575439553Bone Screws, and Cancellous Bone Screw
04026575439546Bone Screws, and Cancellous Bone Screw
04026575534821Shoulder glenoid fossa prosthesis trial - LINK Embrace Shoulder System
04026575534814Shoulder glenoid fossa prosthesis trial - LINK Embrace Shoulder System
04026575534807Shoulder glenoid fossa prosthesis trial - LINK Embrace Shoulder System
04026575534791Shoulder glenoid fossa prosthesis trial - LINK Embrace Shoulder System
04026575534784Shoulder glenoid fossa prosthesis trial - LINK Embrace Shoulder System
04026575534777Shoulder glenoid fossa prosthesis trial - LINK Embrace Shoulder System
04026575534760Surgical drill guide, reusable - LINK Embrace Shoulder System
04026575534753Surgical depth gauge, reusable - LINK Embrace Shoulder System
04026575534722Surgical drill guide, reusable - LINK Embrace Shoulder System
04026575439782Instrument tray - LINK Embrace Shoulder System
04026575439775Instrument tray - LINK Embrace Shoulder System
04026575439768Instrument tray - LINK Embrace Shoulder System
04026575439751Surgical instrument handle, non-torque-limiting - LINK Embrace Shoulder System
04026575439744Fluted surgical drill bit, reusable - LINK Embrace Shoulder System
04026575439737Fluted surgical drill bit, reusable - LINK Embrace Shoulder System
04026575439720Fluted surgical drill bit, reusable - LINK Embrace Shoulder System
04026575439690Fluted surgical drill bit, reusable - LINK Embrace Shoulder System

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