Ibis

GUDID 00822409019489

Diameter 5.5 mm x 75 mm Straight Bulleted Rod Ti

Ortho Development Corporation

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00822409019489
• NIH Device Record Key: febdbd69-ea8f-480d-8000-56e68a1f8618
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ibis
• Version Model Number: 158-1075-03A
• Company DUNS: 876542390
• Company Name: Ortho Development Corporation
• Device Count: 1
• DM Exempt: true
• 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: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com

Device Dimensions

• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409019489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142146

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

On-Brand Devices [Ibis]

• 00822409029907: Diameter 8.5 mm x 60 mm Cannulated Monoaxial Screw
• 00822409029884: Diameter 8.5 mm x 60 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029877: Diameter 8.5 mm x 60 mm Cannulated Polyaxial Screw
• 00822409029846: Diameter 8.5 mm x 55 mm Cannulated Monoaxial Screw
• 00822409029822: Diameter 8.5 mm x 55 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029815: Diameter 8.5 mm x 55 mm Cannulated Polyaxial Screw
• 00822409029785: Diameter 8.5 mm x 50 mm Cannulated Monoaxial Screw
• 00822409029761: Diameter 8.5 mm x 50 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029754: Diameter 8.5 mm x 50 mm Cannulated Polyaxial Screw
• 00822409029723: Diameter 8.5 mm x 45 mm Cannulated Monoaxial Screw
• 00822409029709: Diameter 8.5 mm x 45 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029693: Diameter 8.5 mm x 45 mm Cannulated Polyaxial Screw
• 00822409029662: Diameter 8.5 mm x 40 mm Cannulated Monoaxial Screw
• 00822409029648: Diameter 8.5 mm x 40 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029631: Diameter 8.5 mm x 40 mm Cannulated Polyaxial Screw
• 00822409029600: Diameter 8.5 mm x 35 mm Cannulated Monoaxial Screw
• 00822409029587: Diameter 8.5 mm x 35 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029570: Diameter 8.5 mm x 35 mm Cannulated Polyaxial Screw
• 00822409029549: Diameter 8.5 mm x 30 mm Cannulated Monoaxial Screw
• 00822409029525: Diameter 8.5 mm x 30 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029518: Diameter 8.5 mm x 30 mm Cannulated Polyaxial Screw
• 00822409029457: Diameter 7.5 mm x 60 mm Cannulated Monoaxial Screw
• 00822409029433: Diameter 7.5 mm x 60 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029426: Diameter 7.5 mm x 60 mm Cannulated Polyaxial Screw
• 00822409029396: Diameter 7.5 mm x 55 mm Cannulated Monoaxial Screw
• 00822409029372: Diameter 7.5 mm x 55 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029365: Diameter 7.5 mm x 55 mm Cannulated Polyaxial Screw
• 00822409029334: Diameter 7.5 mm x 50 mm Cannulated Monoaxial Screw
• 00822409029310: Diameter 7.5 mm x 50 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029303: Diameter 7.5 mm x 50 mm Cannulated Polyaxial Screw
• 00822409029273: Diameter 7.5 mm x 45 mm Cannulated Monoaxial Screw
• 00822409029259: Diameter 7.5 mm x 45 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029242: Diameter 7.5 mm x 45 mm Cannulated Polyaxial Screw
• 00822409029211: Diameter 7.5 mm x 40 mm Cannulated Monoaxial Screw
• 00822409029198: Diameter 7.5 mm x 40 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029181: Diameter 7.5 mm x 40 mm Cannulated Polyaxial Screw
• 00822409029150: Diameter 7.5 mm x 35 mm Cannulated Monoaxial Screw
• 00822409029136: Diameter 7.5 mm x 35 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029129: Diameter 7.5 mm x 35 mm Cannulated Polyaxial Screw
• 00822409029099: Diameter 7.5 mm x 30 mm Cannulated Monoaxial Screw
• 00822409029075: Diameter 7.5 mm x 30 mm, 90 mm Cannulated Screw Extended Tab
• 00822409029068: Diameter 7.5 mm x 30 mm Cannulated Polyaxial Screw
• 00822409029006: Diameter 6.5 mm x 60 mm Cannulated Monoaxial Screw
• 00822409028986: Diameter 6.5 mm x 60 mm, 90 mm Cannulated Screw Extended Tab
• 00822409028979: Diameter 6.5 mm x 60 mm Cannulated Polyaxial Screw
• 00822409028948: Diameter 6.5 mm x 55 mm Cannulated Monoaxial Screw
• 00822409028924: Diameter 6.5 mm x 55 mm, 90 mm Cannulated Screw Extended Tab
• 00822409028917: Diameter 6.5 mm x 55 mm Cannulated Polyaxial Screw
• 00822409028887: Diameter 6.5 mm x 50 mm Cannulated Monoaxial Screw
• 00822409028863: Diameter 6.5 mm x 50 mm, 90 mm Cannulated Screw Extended Tab