FDA.reportPublic FDA data

NEO Modera Pedicle Screw System

Primary DI
00815730022457
Brand
NEO Modera Pedicle Screw System
Company
NEW ERA ORTHOPEDICS LLC
Model
A
Catalog number
3PS85-40-01
Device description
Poly-Axial Screw, Solid, Ø8.5mm x 40mm
Published
2016-10-25
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
00815730022457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815730022457008157300224578157300224570815730022457

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-09-17
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00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
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