ODI 7.0mm Cannulated Screw System

GUDID B058CSS7021101

ODI 7.0mm Cannulated Screw – 7.0mm x 110mm

Orthopedic Designs North America, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: B058CSS7021101
• NIH Device Record Key: 3f456d2f-f364-4b6b-881a-9c1583f24f4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ODI 7.0mm Cannulated Screw System
• Version Model Number: CSS702110
• Company DUNS: 945518848
• Company Name: Orthopedic Designs North America, 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: true
• 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: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com

Device Dimensions

• Length: 110 Millimeter
• Outer Diameter: 7 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058CSS7021101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030619

FDA Product Code

• HTN: Washer, Bolt Nut

Sterilization

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

[B058CSS7021101]

Moist Heat or Steam Sterilization

[B058CSS7021101]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-22

On-Brand Devices [ODI 7.0mm Cannulated Screw System]

• B058CSS7021101: ODI 7.0mm Cannulated Screw – 7.0mm x 110mm
• B058CSS7021051: ODI 7.0mm Cannulated Screw – 7.0mm x 105mm
• B058CSS7021001: ODI 7.0mm Cannulated Screw – 7.0mm x 100mm
• B058CSS7020951: ODI 7.0mm Cannulated Screw – 7.0mm x 95mm
• B058CSS7020901: ODI 7.0mm Cannulated Screw – 7.0mm x 90mm
• B058CSS7020851: ODI 7.0mm Cannulated Screw – 7.0mm x 85mm
• B058CSS7020801: ODI 7.0mm Cannulated Screw – 7.0mm x 80mm
• B058CSS7020751: ODI 7.0mm Cannulated Screw – 7.0mm x 75mm
• B058CSS7020701: ODI 7.0mm Cannulated Screw – 7.0mm x 70mm
• B058CSS7020651: ODI 7.0mm Cannulated Screw – 7.0mm x 65mm
• B058CSS7020601: ODI 7.0mm Cannulated Screw – 7.0mm x 60mm
• B058CSS0011371: Washer