Shoulder System

GUDID 07630040734097

Long humeral diaphysis - L200 - 12

Medacta International SA

Total shoulder prosthesis

• Primary Device ID: 07630040734097
• NIH Device Record Key: a2e088ca-4d4b-4963-9efa-2c1013e6599f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder System
• Version Model Number: 04.01.0230
• 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	07630040734097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192967

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer 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: 2020-04-07
• Device Publish Date: 2020-03-30

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