intellijoint KNEE(R)

GUDID 00628184519004

Bone Screw

Intellijoint Surgical Inc

Orthopaedic stereotactic surgery system

• Primary Device ID: 00628184519004
• NIH Device Record Key: 8c9de0c1-59a9-4b65-a7e1-6f7507ffdbb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: intellijoint KNEE(R)
• Version Model Number: 000-0519
• Company DUNS: 202958070
• Company Name: Intellijoint Surgical Inc
• Device Count: 2
• 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: 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	00628184519004 [Primary]
GS1	90628184005197 [Unit of Use]

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

[00628184519004]

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: 2019-12-06

Devices Manufactured by Intellijoint Surgical Inc

• 00628184008003 - intellijoint HIP (R): 2024-07-08 Intellijoint HIP Kit Lateral Platform
• 00628184008010 - intellijoint HIP (R): 2024-07-08 Intellijoint HIP Kit Ellipse Disc
• 00628184008027 - intellijoint KNEE (R): 2024-07-08 Intellijoint KNEE Kit
• 00628184008034 - intellijoint HIP (R): 2024-07-08 Intellijoint HIP Kit, Long Femur Screw - 10 Pack
• 00628184008119 - intellijoint HIP (R): 2024-07-08 Pelvic Screw (136 mm) Sterile
• 00628184008126 - intellijoint HIP (R): 2024-07-08 Femur Screw (18 mm) Sterile
• 00628184008133 - intellijoint HIP (R): 2024-07-08 Femur Screw (26 mm) Sterile
• 00628184008140 - intellijoint HIP (R): 2024-07-08 Femoral Disc, Ellipse Sterile