Lock Activator CLA-001

GUDID 10855068008423

Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture.

Curvafix Inc

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

Primary Device ID	10855068008423
NIH Device Record Key	f2c32d3e-a7ae-4bcd-8b84-6100977733be
Commercial Distribution Status	In Commercial Distribution
Brand Name	Lock Activator
Version Model Number	CLA-001
Catalog Number	CLA-001
Company DUNS	039779098
Company Name	Curvafix 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	false
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	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	425-276-8800
Email	support@curvafix.com
Phone	425-276-8800
Email	support@curvafix.com
Phone	425-276-8800
Email	support@curvafix.com
Phone	425-276-8800
Email	support@curvafix.com
Phone	425-276-8800
Email	support@curvafix.com
Phone	425-276-8800
Email	support@curvafix.com
Phone	425-276-8800
Email	support@curvafix.com
Phone	425-276-8800
Email	support@curvafix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10855068008423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K180050

FDA Product Code

HSB	Rod, Fixation, Intramedullary And Accessories