FDA.reportPublic FDA data

PressON™

Primary DI
B6785208800
Brand
PressON™
Company
NEXUS SPINE, L.L.C.
Model
520880
Device description
Max Telescoping Hybrid Coupler 28mm
Published
2022-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133287000
K160820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133287000PRESSON SPINAL FIXATION SYSTEMNexus Spine, LLC2014-02-25MNH
K160820000PressON Pro Spinal Fixation SystemNexus Spine, LLC2016-06-28NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6785208800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of 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. Sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028137605
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6785221580Tranquil-L™5221582021-12-17
B6785221590Tranquil-L™5221592021-12-17
B6785221600Tranquil-L™5221602021-12-17
B6785221610Tranquil-L™5221612021-12-17
B6785221620Tranquil-L™5221622021-12-17
B6785221630Tranquil-L™5221632021-12-17
B6785221640Tranquil-L™5221642021-12-17
B6785221650Tranquil-L™5221652021-12-17
B6785221660Tranquil-L™5221662021-12-17
B6785221670Tranquil-L™5221672021-12-17
B6785221680Tranquil-L™5221682021-12-17
B6785221690Tranquil-L™5221692021-12-17
B6785221700Tranquil-L™5221702021-12-17
B6785221710Tranquil-L™5221712021-12-17
B6785221720Tranquil-L™5221722021-12-17
B6785221730Tranquil-L™5221732021-12-17
B6785221740Tranquil-L™5221742021-12-17
B6785221750Tranquil-L™5221752021-12-17
B6785221760Tranquil-L™5221762021-12-17
B6785221770Tranquil-L™5221772021-12-17

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Primary DI, Brand, Company table
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