NEO Modera Pedicle Screw System 3PS55-40-01

GUDID 00815730022198

Poly-Axial Screw, Solid, Ø5.5mm x 40mm

NEW ERA ORTHOPEDICS LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00815730022198
• NIH Device Record Key: 94f43ecd-13cc-4bf4-99dc-ad774dd22ff2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEO Modera Pedicle Screw System
• Version Model Number: A
• Catalog Number: 3PS55-40-01
• Company DUNS: 079375910
• Company Name: NEW ERA ORTHOPEDICS LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7175856785
• Email: info@neweraortho.com
• Phone: 7175856785
• Email: info@neweraortho.com
• Phone: 7175856785
• Email: info@neweraortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815730022198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141253

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00815730022198]

Moist Heat or Steam Sterilization

[00815730022198]

Moist Heat or Steam Sterilization

[00815730022198]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-15
• Device Publish Date: 2016-10-25

On-Brand Devices [NEO Modera Pedicle Screw System]

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• 00815730020958: Poly-Axial Screw Assembly, Reduction, Solid, Ø5.5mm x 50mm
• 00815730020941: Poly-Axial Screw Assembly, Reduction, Solid, Ø5.5mm x 45mm
• 00815730020934: Poly-Axial Screw Assembly, Reduction, Solid, Ø5.5mm x 40mm
• 00815730020927: Poly-Axial Screw Assembly, Reduction, Solid, Ø5.5mm x 35mm
• 00815730020910: Poly-Axial Screw Assembly, Reduction, Solid, Ø5.5mm x 30mm
• 00815730020903: Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 45mm
• 00815730020897: Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 40mm
• 00815730020880: Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 35mm
• 00815730020873: Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 30mm
• 00815730020866: Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 25mm
• 00815730020859: Poly-Axial Screw Assembly, Reduction, Solid, Ø4.5mm x 20mm
• 00815730020842: Poly-Axial Screw, Solid, Ø7.5mm x 55mm
• 00815730020835: Poly-Axial Screw Assembly, Solid, Ø7.5mm x 50mm
• 00815730020828: Poly-Axial Screw Assembly, Solid, Ø7.5mm x 45mm
• 00815730020811: Poly-Axial Screw Assembly, Solid, Ø7.5mm x 40mm
• 00815730020804: Poly-Axial Screw Assembly, Solid, Ø7.5mm x 35mm
• 00815730020798: Poly-Axial Screw Assembly, Solid, Ø7.5mm x 30mm
• 00815730020781: Poly-Axial Screw Assembly, Solid, Ø6.5mm x 55mm
• 00815730020774: Poly-Axial Screw Assembly, Solid, Ø6.5mm x 50mm
• 00815730020767: Poly-Axial Screw Assembly, Solid, Ø6.5mm x 45mm
• 00815730020750: Poly-Axial Screw Assembly, Solid, Ø6.5mm x 40mm
• 00815730020743: Poly-Axial Screw Assembly, Solid, Ø6.5mm x 35mm
• 00815730020736: Poly-Axial Screw Assembly, Solid, Ø6.5mm x 30mm
• 00815730020729: Poly-Axial Screw Assembly, Solid, Ø5.5mm x 55mm
• 00815730020712: Poly-Axial Screw Assembly, Solid, Ø5.5mm x 50mm
• 00815730020705: Poly-Axial Screw Assembly, Solid, Ø5.5mm x 45mm
• 00815730020699: Poly-Axial Screw Assembly, Solid, Ø5.5mm x 40mm
• 00815730020682: Poly-Axial Screw Assembly, Solid, Ø5.5mm x 35mm
• 00815730020675: Poly-Axial Screw Assembly, Solid, Ø5.5mm x 30mm
• 00815730020668: Poly-Axial Screw Assembly, Solid, Ø4.5mm x 45mm
• 00815730020651: Poly-Axial Screw Assembly, Solid, Ø4.5mm x 40mm
• 00815730020644: Poly-Axial Screw Assembly, Solid, Ø4.5mm x 35mm
• 00815730020637: Poly-Axial Screw Assembly, Solid, Ø4.5mm x 30mm
• 00815730020620: Poly-Axial Screw Assembly, Solid, Ø4.5mm x 25mm
• 00815730020613: Poly-Axial Screw Assembly, Solid, Ø4.5mm x 20mm
• 00815730020606: Rod, Curved, Co-Cr, Ø5.5mm x 150mm
• 00815730020590: Rod, Curved, Co-Cr, Ø5.5mm x 140mm
• 00815730020583: Rod, Curved, Co-Cr, Ø5.5mm x 130mm
• 00815730020576: Rod, Curved, Co-Cr, Ø5.5mm x 120mm
• 00815730020569: Rod, Curved, Co-Cr, Ø5.5mm x 110mm
• 00815730020552: Rod, Curved, Co-Cr, Ø5.5mm x 100mm
• 00815730020545: Rod, Curved, Co-Cr, Ø5.5mm x 90mm
• 00815730020538: Rod, Curved, Co-Cr, Ø5.5mm x 80mm
• 00815730020521: Rod, Curved, Co-Cr, Ø5.5mm x 75mm
• 00815730020514: Rod, Curved, Co-Cr, Ø5.5mm x 70mm
• 00815730020507: Rod, Curved, Co-Cr, Ø5.5mm x 60mm
• 00815730020491: Rod, Curved, Co-Cr, Ø5.5mm x 55mm
• 00815730020484: Rod, Curved, Co-Cr, Ø5.5mm x 50mm