R1 Reverse Shoulder System

GUDID 00811596030728

Glenosphere Locking Screw

CATALYST ORTHOSCIENCE INC.

Total reverse shoulder prosthesis

• Primary Device ID: 00811596030728
• NIH Device Record Key: c08c46bb-aee4-428f-9620-9017dbd933f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R1 Reverse Shoulder System
• Version Model Number: 1230-7515-001
• Company DUNS: 079702565
• Company Name: CATALYST ORTHOSCIENCE INC.
• 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: 800-587-5137
• Email: info@catalystortho.com
• Phone: 800-587-5137
• Email: info@catalystortho.com
• Phone: 800-587-5137
• Email: info@catalystortho.com
• Phone: 800-587-5137
• Email: info@catalystortho.com
• Phone: 800-587-5137
• Email: info@catalystortho.com
• Phone: 800-587-5137
• Email: info@catalystortho.com
• Phone: 800-587-5137
• Email: info@catalystortho.com
• Phone: 800-587-5137
• Email: info@catalystortho.com
• Phone: 800-587-5137
• Email: info@catalystortho.com
• Phone: 800-587-5137
• Email: info@catalystortho.com
• Phone: 800-587-5137
• Email: info@catalystortho.com
• Phone: 800-587-5137
• Email: info@catalystortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811596030728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202611

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

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: 2021-03-08
• Device Publish Date: 2021-02-28

On-Brand Devices [R1 Reverse Shoulder System]

• 00811596030728: Glenosphere Locking Screw
• 00811596030711: Glenosphere 40mm - Lateral
• 00811596030704: Glenosphere 40mm - Standard
• 00811596030698: Glenosphere 36mm - Lateral
• 00811596030681: Glenosphere 36mm - Standard
• 00811596030674: Glenosphere 32mm - Lateral
• 00811596030667: Glenosphere 32mm - Standard
• 00811596030650: Peripheral Screw 4.5mm - 36mm
• 00811596030643: Peripheral Screw 4.5mm - 32mm
• 00811596030636: Peripheral Screw 4.5mm - 28mm
• 00811596030629: Peripheral Screw 4.5mm - 24mm
• 00811596030612: Peripheral Screw 4.5mm - 20mm
• 00811596030605: Peripheral Screw 4.5mm - 16mm
• 00811596030599: Peripheral Screw 4.5mm - 12mm
• 00811596030582: Center Post 6.5mm - 35mm
• 00811596030575: Center Post 6.5mm - 25mm
• 00811596030568: Center Screw 6.5mm - 40mm
• 00811596030551: Center Screw 6.5mm - 30mm
• 00811596030544: Center Screw 6.5mm - 20mm
• 00811596030537: Augmented Baseplate 10°
• 00811596030520: Standard Baseplate
• 00811596030513: Poly Insert 40mm +12
• 00811596030506: Poly Insert 40mm +8
• 00811596030490: Poly Insert 40mm +4
• 00811596030483: Poly Insert 40mm +0
• 00811596030476: Poly Insert 36mm +12
• 00811596030469: Poly Insert 36mm +8
• 00811596030452: Poly Insert 36mm +4
• 00811596030445: Poly Insert 36mm +0
• 00811596030438: Poly Insert 32mm +12
• 00811596030421: Poly Insert 32mm +8
• 00811596030414: Poly Insert 32mm +4
• 00811596030407: Poly Insert 32mm +0
• 00811596030391: Humeral Stem Long - 41mm
• 00811596030384: Humeral Stem Long - 36mm
• 00811596030377: Humeral Stem Short - 41mm
• 00811596030360: Humeral Stem Short - 36mm
• 00811596030896: Long Broach 36mm
• 00811596030889: Short Broach 41mm
• 00811596030872: Short Broach 36mm
• 00811596030865: Stem Handle ASM
• 00811596030858: Humeral Drill
• 00811596030841: Humeral Drill Guide 41mm
• 00811596030834: Humeral Drill Guide 36mm
• 00811596030827: Reamer Drive Shaft
• 00811596030810: Reamer Head 41mm
• 00811596030803: Reamer Head 36mm
• 00811596030797: Reamer Guide Plate 41mm
• 00811596030780: Reamer Guide Plate 36mm
• 00811596030773: Humeral Head Protector