FDA.reportPublic FDA data

PressON Pedicle Screw System

Primary DI
B678520486S0
Brand
PressON Pedicle Screw System
Company
NEXUS SPINE, L.L.C.
Model
520486S
Device description
Double Coupler 54mm
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223529000PressON Spinal Fixation SystemNexus Spine, LLC2023-05-02NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B678520486S0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Regulatory Flags#

DUNS number
028137605
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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