TiLock2 Pedicle Screw System GCL125-S

GUDID M719GLC125S0

K-Wire Tube - Short

Genesys Orthopedics Systems LLC

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Primary Device ID	M719GLC125S0
NIH Device Record Key	cf006729-7d7b-4b93-b0e5-52bef585c828
Commercial Distribution Status	In Commercial Distribution
Brand Name	TiLock2 Pedicle Screw System
Version Model Number	1
Catalog Number	GCL125-S
Company DUNS	017921066
Company Name	Genesys Orthopedics Systems LLC
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	5123817070
Email	info@genesysspine.com
Phone	5123817070
Email	info@genesysspine.com
Phone	5123817070
Email	info@genesysspine.com
Phone	5123817070
Email	info@genesysspine.com
Phone	5123817070
Email	info@genesysspine.com
Phone	5123817070
Email	info@genesysspine.com
Phone	5123817070
Email	info@genesysspine.com
Phone	5123817070
Email	info@genesysspine.com
Phone	5123817070
Email	info@genesysspine.com
Phone	5123817070
Email	info@genesysspine.com
Phone	5123817070
Email	info@genesysspine.com
Phone	5123817070
Email	info@genesysspine.com
Phone	5123817070
Email	info@genesysspine.com
Phone	5123817070
Email	info@genesysspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GLC125S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171838

FDA Product Code

NKB	Thoracolumbosacral Pedicle Screw System