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NEO Modera Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by New Era Orthopedics Llc

Identity

Trade Name
NEO Modera Pedicle Screw System FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Device Name
Rod, Curved, Co-Cr, Ø5.5mm x 30mm FDA UDI
Model / Reference
A FDA UDI
Description
Rod, Curved, Co-Cr, Ø5.5mm x 30mm FDA UDI

Identifiers

Catalog Number
3RCC55-30 FDA UDI
Primary DI / UDI-DI
00815730020446 FDA UDI
510(k) Number
K141253 FDA UDI
FDA Product Code
MNI FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Trans-facet-screw internal spinal fixation system, sterile

NEO Modera Pedicle Screw System by New Era Orthopedics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trans-facet-screw internal spinal fixation system, sterile.

Cleared under the same submission

K141253 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
New Era Orthopedics Llc

Sources (1)

  • FDA UDI cb3559e1-2c5f-4334-9123-a3e8c1a2af48 36 fields · synced May 30, 2026