intellijoint HIP®

GUDID 00628184003763

Femoral Disc, Round, Sterile

Intellijoint Surgical Inc

Orthopaedic stereotactic surgery system

• Primary Device ID: 00628184003763
• NIH Device Record Key: 7ab696a0-f4e8-4963-af83-fd45842ae977
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: intellijoint HIP®
• Version Model Number: 000-0376
• 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: 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: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com
• Phone: 1-519-342-3178
• Email: info@intellijointsurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628184003763 [Primary]
GS1	10628184003760 [Package]; Package: Shelf Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172849

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

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: 2020-03-09
• Device Publish Date: 2019-02-20

On-Brand Devices [intellijoint HIP®]

• 00628184003732: Femoral Disc, Ellipse
• 00628184003688: Magnetic, Inserter, Femoral Disc, Nails, G2
• 00628184003664: Magnetic, Femoral Disc, Nails, G2
• 00628184003589: Inserter, Femoral Disc, Nails, G2
• 00628184003565: Femoral Disc, Nails, G2
• 00628184003008: System, Intellijoint HIP, Portable, Demo
• 00628184002858: Pelvic Screw - LNG (136 mm)
• 00628184002841: Femur Screw - LNG (26 mm)
• 00628184002834: Femur Screw - STD (18 mm)
• 00628184002827: Pelvic Screw - STD (116 mm)
• 00628184002803: Rod, Washer, 138 mm
• 00628184002759: Washer, Grooved, 14 mm, G2
• 00628184002728: Extender, Femur Platform, G2
• 00628184002704: Arm, Camera Mount, Magnetic Base
• 00628184002605: Probe, G2, 120 mm Tip
• 00628184002520: CCU, G2
• 00628184002513: Camera, G2
• 00628184002506: System, Intellijoint HIP, Cart
• 00628184002490: System, Intellijoint HIP, Portable
• 00628184002476: Bit, 3.5mm Hex Split, Captive, G2
• 00628184002414: Workstation, G2, Configured
• 00628184002346: Screw, Pelvic, G2, 136mm
• 00628184002339: Screw, Femur, G2, 26mm
• 00628184002292: Guide, Pelvic Screw, G2, 25mm
• 00628184002148: Platform, Pelvic, G2, 25mm
• 00628184002117: Platform, Femur, G2, 11mm
• 00628184002094: Bit, Power, 3.5mm
• 00628184002087: Driver, T-Handle, 3.5mm
• 00628184002070: Tray, Sterilization, G2
• 00628184002063: V-Block, G2
• 00628184002025: Rod, Alignment, G2
• 00628184001974: Probe, G2
• 00628184001905: Screw, Femur, G2
• 00628184001899: Clamp, Camera, G2
• 00628184001721: Tracker, G2
• 00628184001639: Screw, Pelvic, G2
• 00628184001615: Sleeve, Pelvic Screw, G2
• 00628184001608: Trocar, Pelvic Screw, G2
• 00628184001592: Inserter, Femur Platform, G2
• 00628184001585: Shroud, Camera, G2
• 00628184001523: Platform, Femur, G2
• 00628184003770: Femoral Disc, Ellipse, Sterile
• 00628184003763: Femoral Disc, Round, Sterile
• 00628184003879: Pelvic Platform, 25 mm, 10 degrees tilt
• 00628184003930: Pelvic Platform, Mini
• 00628184004012: Angled Probe