CORE Shoulder System

GUDID 00810022403129

16mm Probe - Left

Link Bio Corp

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00810022403129
• NIH Device Record Key: 561213ac-4b75-453e-a49e-9bd168baf07b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORE Shoulder System
• Version Model Number: 87-9133/16L
• Company DUNS: 827608774
• Company Name: Link Bio Corp
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00810022403129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241470

FDA Product Code

• QHE: Shoulder Arthroplasty Implantation System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810022403129]

Moist Heat or Steam Sterilization

[00810022403129]

Moist Heat or Steam Sterilization

[00810022403129]

Moist Heat or Steam Sterilization

[00810022403129]

Moist Heat or Steam Sterilization

[00810022403129]

Moist Heat or Steam Sterilization

[00810022403129]

Moist Heat or Steam Sterilization

[00810022403129]

Moist Heat or Steam Sterilization

[00810022403129]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-12
• Device Publish Date: 2025-06-04

On-Brand Devices [CORE Shoulder System]

• 00810022403204: Drill Guide Probe
• 00810022403198: 28mm Probe - Right
• 00810022403181: 24mm Probe - Right
• 00810022403174: 20mm Probe - Right
• 00810022403167: 16mm Probe - Right
• 00810022403150: 28mm Probe - Left
• 00810022403143: 24mm Probe - Left
• 00810022403136: 20mm Probe - Left
• 00810022403129: 16mm Probe - Left
• 00810022403112: Stand/Cart for Workstation
• 00810022403105: Workstation AC Power Adapter
• 00810022403099: Workstation
• 00810022403082: Instrument Tray
• 00810022403068: COREmote - Power Unit
• 00810022403051: COREmote - Sensor Unit