intellijoint KNEE®

GUDID 00628184005309

Positioning Paddle

Intellijoint Surgical Inc

Orthopaedic stereotactic surgery system

• Primary Device ID: 00628184005309
• NIH Device Record Key: 5dc9d457-1bb1-43fa-bd4c-1fff1c0761e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: intellijoint KNEE®
• Version Model Number: 000-0530
• Company DUNS: 202958070
• Company Name: Intellijoint Surgical 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: 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

Customer Support Contacts

• Phone: 15193423178
• Email: info@intellijointsurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628184005309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191507

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00628184005309]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-09
• Device Publish Date: 2019-10-11

On-Brand Devices [intellijoint KNEE®]

• 00628184005514: Bone Tracker
• 00628184005460: Instrument Tray
• 00628184005415: Camera Mount
• 00628184005361: Dual Slot Cutting Guide
• 00628184005309: Positioning Paddle
• 00628184005262: Probe Verification Jig
• 00628184005217: Bone Tracker
• 00628184005194: Bone Screw
• 00628184005132: Adjustable Cutting Guide Top
• 00628184005088: Adjustable Cutting Guide Base
• 00628184005026: Probe Tracker
• 00628184005019: Instrument Tray, Knee
• 00628184005507: Bone Pin, 3.2 mm x 75 mm
• 00628184005187: Bone Pin, 3.2 mm x 90 mm
• 00628184005613: Probe Adaptor 1.7 - 1.8mm
• 00628184005606: Probe Adaptor 1.5 - 1.6mm
• 00628184005590: Probe Adaptor 1.3 - 1.4mm
• 00628184005668: Rotational Sizer Interface