HemiCAPGRS® G203-2015-W

GUDID M528G2032015W0

ARTICULAR, 19 x 20mm IMPLANT, GLENOID 53/50 HEAD

ARTHROSURFACE INCORPORATED

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: M528G2032015W0
• NIH Device Record Key: fb59936b-1aa0-4cd3-8c24-2a02b7e927de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemiCAPGRS®
• Version Model Number: G203-2015-W
• Catalog Number: G203-2015-W
• Company DUNS: 144666109
• Company Name: ARTHROSURFACE INCORPORATED
• 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

Customer Support Contacts

• Phone: 508-520-3003
• Email: contact@arthrosurface.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M528G2032015W0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091196

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2015-09-15

On-Brand Devices [HemiCAPGRS®]

• M528G2032520W0: ARTICULAR, 20 X 25MM IMPLANT, GLENOID 53/50 HEAD
• M528G2032520A0: ARTICULAR, 20 X 25MM IMPLANT, GLENOID 53/50 HEAD
• M528G2032515W0: ARTICULAR, 20 x 25mm IMPLANT, GLENOID 58/55 HEAD
• M528G2032515A0: ARTICULAR, 20 x 25mm IMPLANT, GLENOID 58/55 HEAD
• M528G2032015W0: ARTICULAR, 19 x 20mm IMPLANT, GLENOID 53/50 HEAD
• M528G2032015A0: ARTICULAR, 19 x 20mm IMPLANT, GLENOID 53/50 HEAD
• M528G2032010W0: ARTICULAR, 19 x 20mm IMPLANT, GLENOID 58/55 HEAD
• M528G2032010A0: ARTICULAR, 19 x 20mm IMPLANT, GLENOID 58/55 HEAD
• M528G00714000: Glenoid Pin Kit
• M528G00002000: Glenoid Universal Delivery Kit-Twin Glenoid
• M528G00001000: Glenoid Universal Delivery Kit