Cancellous Bone Screw WF-1-1007

GUDID B046WF110070

45mm x 6.5mm Cancellous Bone Screw

SIGNAL MEDICAL CORPORATION

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

Primary Device ID	B046WF110070
NIH Device Record Key	5eaeb8f6-5b84-45af-9f95-137d804ab867
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cancellous Bone Screw
Version Model Number	45mm
Catalog Number	WF-1-1007
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	B046WF110070 [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