Shoulder System

GUDID 07630345716781

Humeral eccentric reverse metaphysis +0mm/+3mm

Medacta International SA

Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis

• Primary Device ID: 07630345716781
• NIH Device Record Key: 7878694c-352f-4b7e-b33b-1d9490f5628e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder System
• Version Model Number: 04.01.0284
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• 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: true
• Serial Number: false
• 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	07630345716781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210207

FDA Product Code

• MBF: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

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: 2021-04-06
• Device Publish Date: 2021-03-29

On-Brand Devices [Shoulder System]

• 07630040719964: Glenoid Polyaxial non-locking screw – L50
• 07630040719957: Glenoid Polyaxial non-locking screw – L46
• 07630040719940: Glenoid Polyaxial non-locking screw – L42
• 07630040719933: Glenoid Polyaxial non-locking screw – L38
• 07630040719926: Glenoid Polyaxial non-locking screw – L34
• 07630040719919: Glenoid Polyaxial non-locking screw – L30
• 07630040719902: Glenoid Polyaxial non-locking screw – L26
• 07630040719896: Glenoid Polyaxial non-locking screw – L22
• 07630040719889: Glenoid Polyaxial non-locking screw – L18
• 07630040719872: Glenoid Polyaxial non-locking screw – L14
• 07630040715492: Threaded glenoid baseplate Ø27x30
• 07630040715485: Threaded glenoid baseplate Ø27x25
• 07630040715478: Threaded glenoid baseplate Ø24.5x30
• 07630040708135: Glenoidsphere 32xØ24.5
• 07630040708098: Threaded glenoid baseplate Ø24.5x25
• 07630040706636: Glenoidsphere screw
• 07630040706629: Double Eccenter / Reverse metaphysis screw
• 07630040706612: Glenoidsphere 42x27
• 07630040706605: Glenoidsphere 39xØ27
• 07630040706599: Glenoidsphere 36xØ27
• 07630040706582: Glenoidsphere 42xØ24.5
• 07630040706575: Glenoidsphere 39xØ24.5
• 07630040706568: Glenoidsphere 36xØ24.5
• 07630040706551: Glenoidsphere 36xØ22
• 07630040706544: Glenoidsphere 32xØ22
• 07630040706537: Glenoid polyaxial locking screw - L50
• 07630040706520: Glenoid polyaxial locking screw - L46
• 07630040706513: Glenoid polyaxial locking screw - L42
• 07630040706506: Glenoid polyaxial locking screw - L38
• 07630040706490: Glenoid polyaxial locking screw - L34
• 07630040706483: Glenoid polyaxial locking screw - L30
• 07630040706476: Glenoid polyaxial locking screw - L26
• 07630040706469: Glenoid polyaxial locking screw - L22
• 07630040706452: Glenoid polyaxial locking screw - L18
• 07630040706445: Glenoid polyaxial locking screw - L14
• 07630040706438: Glenoid baseplate Ø27x35
• 07630040706421: Glenoid baseplate Ø27x25
• 07630040706414: Glenoid baseplate Ø27x15
• 07630040706407: Glenoid baseplate Ø24.5x35
• 07630040706391: Glenoid baseplate Ø24.5x25
• 07630040706384: Glenoid baseplate Ø24.5x15
• 07630040706377: Glenoid baseplate Ø22x35
• 07630040706360: Glenoid baseplate Ø22x25
• 07630040706353: Glenoid baseplate Ø22x15
• 07630040706346: Humeral Reverse HC Liner Ø42/+6mm
• 07630040706339: Humeral Reverse HC Liner Ø42/+3mm
• 07630040706322: Humeral Reverse HC Liner Ø42/+0mm
• 07630040706315: Humeral Reverse HC Liner Ø39/+6mm
• 07630040706308: Humeral Reverse HC Liner Ø39/+3mm
• 07630040706292: Humeral Reverse HC Liner Ø39/+0mm