TiLock2 Pedicle Screw System GLC484

GUDID M719GLC4840

MIS Arc Distractor

Genesys Orthopedics Systems LLC

Orthopaedic surgical distractor, internal
Primary Device IDM719GLC4840
NIH Device Record Keybb06a991-a824-4978-a52b-bd4254e97709
Commercial Distribution StatusIn Commercial Distribution
Brand NameTiLock2 Pedicle Screw System
Version Model Number1
Catalog NumberGLC484
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
HIBCCM719GLC4840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

Moist Heat or Steam Sterilization


[M719GLC4840]

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

On-Brand Devices [TiLock2 Pedicle Screw System]

M719GLC48220DMDSA Modular Screw Blade
M719GLC48210DMDSA Modular Screw Blade
M719GLC4810DMDSA Central Retractor Driver
M719GLC4670DMDSA Central Retractor
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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