TiLock2 Pedicle Screw System GL322

GUDID M719GL3220

4-Sided Fixed Handle

Genesys Orthopedics Systems LLC

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting
Primary Device IDM719GL3220
NIH Device Record Key28b5876f-f2db-4e13-a9fd-6348a132f3d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTiLock2 Pedicle Screw System
Version Model Number1
Catalog NumberGL322
Company DUNS017921066
Company NameGenesys Orthopedics Systems LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM719GL3220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

[M719GL3220]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-16
Device Publish Date2020-10-08

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M719GLC429S0MIS Locking Star Setcap Starter - Short
M719GLC125S0K-Wire Tube - Short
M719GLC4840MIS Arc Distractor
M719GL32704-Sided Push Collar Ratchet Handle
M719GL32204-Sided Fixed Handle
M719GLC7000MIS Arc Distractor Variable Shaft
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