FDA.reportPublic FDA data

NEO Modera Pedicle Screw System

Primary DI
00815730020439
Brand
NEO Modera Pedicle Screw System
Company
NEW ERA ORTHOPEDICS LLC
Model
A
Catalog number
3RCC55-25
Device description
Rod, Curved, Co-Cr, Ø5.5mm x 25mm
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141253000NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEMNew Era Orthopaedics, LLC2015-01-09MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815730020439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815730020439008157300204398157300204390815730020439

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7175856785info@neweraortho.com

Regulatory Flags#

DUNS number
079375910
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815730021733NEO Modera Pedicle Screw SystemA3MS45-252016-10-18
00815730020989NEO Modera Pedicle Screw SystemB3PR65-352016-09-21
00815730020996NEO Modera Pedicle Screw SystemB3PR65-402016-09-21
00815730021009NEO Modera Pedicle Screw SystemB3PR65-452016-09-21
00815730021016NEO Modera Pedicle Screw SystemB3PR65-502016-09-21
00815730021023NEO Modera Pedicle Screw SystemB3PR65-552016-09-21
00815730021030NEO Modera Pedicle Screw SystemB3PR75-302016-09-21
00815730021047NEO Modera Pedicle Screw SystemB3PR75-352016-09-21
00815730021054NEO Modera Pedicle Screw SystemB3PR75-402016-09-21
00815730021061NEO Modera Pedicle Screw SystemB3PR75-452016-09-21
00815730021078NEO Modera Pedicle Screw SystemB3PR75-502016-09-21
00815730021085NEO Modera Pedicle Screw SystemB3PR75-552016-09-21
00815730021092NEO Modera Pedicle Screw SystemB3PR75-802016-09-21
00815730021108NEO Modera Pedicle Screw SystemB3PR75-902016-09-21
00815730021115NEO Modera Pedicle Screw SystemB3PR75-1002016-09-21
00815730021122NEO Modera Pedicle Screw SystemB3PR75-1102016-09-21
00815730021139NEO Modera Pedicle Screw SystemB3PR75-1202016-09-21
00815730021146NEO Modera Pedicle Screw SystemB3PR85-302016-09-21
00815730021153NEO Modera Pedicle Screw SystemB3PR85-352016-09-21
00815730021160NEO Modera Pedicle Screw SystemB3PR85-402016-09-21

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