OrthoSolutions 'System26' Bone Screws OS922115-NS

GUDID 05055662960778

8.0MM X 115MM HEADLESS CANNULATED SCREW 19MM THREAD

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 05055662960778
• NIH Device Record Key: 5ad66520-02bb-45b1-a52e-ecf22fcc7e00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoSolutions 'System26' Bone Screws
• Version Model Number: OS922115-NS
• Catalog Number: OS922115-NS
• Company DUNS: 218648211
• Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055662960778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163489

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[05055662960778]

Moist Heat or Steam Sterilization

[05055662960778]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-14