NEO Modera Pedicle Screw System 3MS45-25

GUDID 00815730021733

Mono-Axial Screw, Solid, Ø4.5mm x 25mm

NEW ERA ORTHOPEDICS LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00815730021733
NIH Device Record Keyc066ed3d-4d55-4aea-83e8-187f92100fa9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEO Modera Pedicle Screw System
Version Model NumberA
Catalog Number3MS45-25
Company DUNS079375910
Company NameNEW ERA ORTHOPEDICS LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7175856785
Emailinfo@neweraortho.com
Phone7175856785
Emailinfo@neweraortho.com
Phone7175856785
Emailinfo@neweraortho.com
Phone7175856785
Emailinfo@neweraortho.com
Phone7175856785
Emailinfo@neweraortho.com
Phone7175856785
Emailinfo@neweraortho.com
Phone7175856785
Emailinfo@neweraortho.com
Phone7175856785
Emailinfo@neweraortho.com
Phone7175856785
Emailinfo@neweraortho.com
Phone7175856785
Emailinfo@neweraortho.com
Phone7175856785
Emailinfo@neweraortho.com
Phone7175856785
Emailinfo@neweraortho.com
Phone7175856785
Emailinfo@neweraortho.com
Phone7175856785
Emailinfo@neweraortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815730021733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815730021733]

Moist Heat or Steam Sterilization

[00815730021733]

Moist Heat or Steam Sterilization

[00815730021733]

Moist Heat or Steam Sterilization

[00815730021733]

Moist Heat or Steam Sterilization

[00815730021733]

Moist Heat or Steam Sterilization

[00815730021733]

Moist Heat or Steam Sterilization

[00815730021733]

Moist Heat or Steam Sterilization

[00815730021733]

Moist Heat or Steam Sterilization

[00815730021733]

Moist Heat or Steam Sterilization

[00815730021733]

Moist Heat or Steam Sterilization

[00815730021733]

Moist Heat or Steam Sterilization

[00815730021733]

Moist Heat or Steam Sterilization

[00815730021733]

Moist Heat or Steam Sterilization

[00815730021733]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-08-17
Device Publish Date2016-10-18

On-Brand Devices [NEO Modera Pedicle Screw System]

00815730020972Poly-Axial Screw Assembly, Reduction, Solid, Ø6.5mm x 30mm
00815730020965Poly-Axial Screw Assembly, Reduction, Solid, Ø5.5mm x 55mm
00815730020958Poly-Axial Screw Assembly, Reduction, Solid, Ø5.5mm x 50mm
00815730020941Poly-Axial Screw Assembly, Reduction, Solid, Ø5.5mm x 45mm
00815730020934Poly-Axial Screw Assembly, Reduction, Solid, Ø5.5mm x 40mm
00815730020927Poly-Axial Screw Assembly, Reduction, Solid, Ø5.5mm x 35mm
00815730020910Poly-Axial Screw Assembly, Reduction, Solid, Ø5.5mm x 30mm
00815730020903Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 45mm
00815730020897Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 40mm
00815730020880Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 35mm
00815730020873Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 30mm
00815730020866Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 25mm
00815730020859Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 20mm
00815730020842Poly-Axial Screw, Solid, Ø7.5mm x 55mm
00815730020835Poly-Axial Screw Assembly, Solid, Ø7.5mm x 50mm
00815730020828Poly-Axial Screw Assembly, Solid, Ø7.5mm x 45mm
00815730020811Poly-Axial Screw Assembly, Solid, Ø7.5mm x 40mm
00815730020804Poly-Axial Screw Assembly, Solid, Ø7.5mm x 35mm
00815730020798Poly-Axial Screw Assembly, Solid, Ø7.5mm x 30mm
00815730020781Poly-Axial Screw Assembly, Solid, Ø6.5mm x 55mm
00815730020774Poly-Axial Screw Assembly, Solid, Ø6.5mm x 50mm
00815730020767Poly-Axial Screw Assembly, Solid, Ø6.5mm x 45mm
00815730020750Poly-Axial Screw Assembly, Solid, Ø6.5mm x 40mm
00815730020743Poly-Axial Screw Assembly, Solid, Ø6.5mm x 35mm
00815730020736Poly-Axial Screw Assembly, Solid, Ø6.5mm x 30mm
00815730020729Poly-Axial Screw Assembly, Solid, Ø5.5mm x 55mm
00815730020712Poly-Axial Screw Assembly, Solid, Ø5.5mm x 50mm
00815730020705Poly-Axial Screw Assembly, Solid, Ø5.5mm x 45mm
00815730020699Poly-Axial Screw Assembly, Solid, Ø5.5mm x 40mm
00815730020682Poly-Axial Screw Assembly, Solid, Ø5.5mm x 35mm
00815730020675Poly-Axial Screw Assembly, Solid, Ø5.5mm x 30mm
00815730020668Poly-Axial Screw Assembly, Solid, Ø4.5mm x 45mm
00815730020651Poly-Axial Screw Assembly, Solid, Ø4.5mm x 40mm
00815730020644Poly-Axial Screw Assembly, Solid, Ø4.5mm x 35mm
00815730020637Poly-Axial Screw Assembly, Solid, Ø4.5mm x 30mm
00815730020620Poly-Axial Screw Assembly, Solid, Ø4.5mm x 25mm
00815730020613Poly-Axial Screw Assembly, Solid, Ø4.5mm x 20mm
00815730020606Rod, Curved, Co-Cr, Ø5.5mm x 150mm
00815730020590Rod, Curved, Co-Cr, Ø5.5mm x 140mm
00815730020583Rod, Curved, Co-Cr, Ø5.5mm x 130mm
00815730020576Rod, Curved, Co-Cr, Ø5.5mm x 120mm
00815730020569Rod, Curved, Co-Cr, Ø5.5mm x 110mm
00815730020552Rod, Curved, Co-Cr, Ø5.5mm x 100mm
00815730020545Rod, Curved, Co-Cr, Ø5.5mm x 90mm
00815730020538Rod, Curved, Co-Cr, Ø5.5mm x 80mm
00815730020521Rod, Curved, Co-Cr, Ø5.5mm x 75mm
00815730020514Rod, Curved, Co-Cr, Ø5.5mm x 70mm
00815730020507Rod, Curved, Co-Cr, Ø5.5mm x 60mm
00815730020491Rod, Curved, Co-Cr, Ø5.5mm x 55mm
00815730020484Rod, Curved, Co-Cr, Ø5.5mm x 50mm
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.