Cancellous Bone Screw WF-1-1008

GUDID B046WF110080

50mm x 6.5mm Cancellous Bone Screw

SIGNAL MEDICAL CORPORATION

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: B046WF110080
• NIH Device Record Key: caa9bf86-5b24-474b-a8d7-ae2b5c256856
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cancellous Bone Screw
• Version Model Number: 50mm
• Catalog Number: WF-1-1008
• Company DUNS: 169289308
• Company Name: SIGNAL MEDICAL CORPORATION
• 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: 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: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B046WF110080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961157

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-01
• Device Publish Date: 2019-03-22

On-Brand Devices [Cancellous Bone Screw]

• B046WF110080: 50mm x 6.5mm Cancellous Bone Screw
• B046WF110070: 45mm x 6.5mm Cancellous Bone Screw
• B046WF110050: 35mm x 6.5mm Cancellous Bone Screws
• B046WF110040: 30mm x 6.5mm Cancellous Bone Screw
• B046WF110030: 25mm x 6.5mm Cancellous Bone Screw
• B046WF110020: 20mm x 6.5mm Cancellous Bone Screws
• B046WF110010: 15mm x 6.5mm Cancellous Bone Screw