Lumbar Plate System GLP-10155-28

GUDID M719GLP10155280

5.5mm x 28mm Lumbar Screw

Genesys Orthopedics Systems LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDM719GLP10155280
NIH Device Record Key013c2e63-ef01-460f-bc70-0188b9dd131b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumbar Plate System
Version Model Number1
Catalog NumberGLP-10155-28
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
Phone5123817070
Emailinfo@genesysspine.com

Device Dimensions

Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter
Length28 Millimeter
Width5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM719GLP10155280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

[M719GLP10155280]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-31
Device Publish Date2023-07-21

On-Brand Devices [Lumbar Plate System]

M719GLP10000025025mm Lumbar Plate
M719GLP10000023023mm Lumbar Plate
M719GLP10000021021mm Lumbar Plate
M719GLP10000019019mm Lumbar Plate
M719GLP10000017017mm Lumbar Plate
M719GLP10000015015mm Lumbar Plate
M719GLPV553205.5mm x 32mm Lumbar Plate Variable Screw
M719GLPV552805.5mm x 28mm Lumbar Plate Variable Screw
M719GLPV552405.5mm x 24mm Lumbar Plate Variable Screw
M719GLPV552005.5mm x 20mm Lumbar Plate Variable Screw
M719GLP1630Lumbar Plate LP Basic Screwdriver
M719GLP1620Lumbar Plate Angled Awl Guide
M719GLP1610Lumbar Plate Jointed Driver
M719GLP1600Lumbar Plate Jointed Awl
M719GLP1590Lumbar Plate Helios Driver - Assembly
M719GLP15420Lumbar Plate Shielded Awl, No Spring
M719GLP101553205.5mm x 32mm Lumbar Screw
M719GLP101552805.5mm x 28mm Lumbar Screw
M719GLP101552405.5mm x 24mm Lumbar Screw
M719GLP101552105.5 x 21mm Lumbar Screw
M719GLP1010132032mm Lumbar Plate Drill
M719GLP1010128028mm Lumbar Plate Drill
M719GLP1010124024mm Lumbar Plate Drill
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