FDA.reportPublic FDA data

PressON Pedicle Screw System

Primary DI
B678520241S0
Brand
PressON Pedicle Screw System
Company
NEXUS SPINE, L.L.C.
Model
520241S
Device description
MIS Pedicle Screw 8.5 x 45mm, Cannulated
Published
2025-12-31
Public version status
New
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
K160820000
K223529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160820000PressON Pro Spinal Fixation SystemNexus Spine, LLC2016-06-28NKB
K223529000PressON Spinal Fixation SystemNexus Spine, LLC2023-05-02NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B678520241S0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Millimeter
Width8.5Millimeter

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
B6785209110PressON Pedicle Screw System5209112026-09-04
B6785209120PressON Pedicle Screw System5209122026-09-04
B6785209130PressON Pedicle Screw System5209132026-09-04
B6785209140PressON Pedicle Screw System5209142026-09-04
B6785209150PressON Pedicle Screw System5209152026-09-04
B6785209160PressON Pedicle Screw System5209162026-09-04
B6785209170PressON Pedicle Screw System5209172026-09-04
B6785209180PressON Pedicle Screw System5209182026-09-04
B6785209190PressON Pedicle Screw System5209192026-09-04
B6785209200PressON Pedicle Screw System5209202026-09-04
B6785209210PressON Pedicle Screw System5209212026-09-04
B6785209220PressON Pedicle Screw System5209222026-09-04
B6785209230PressON Pedicle Screw System5209232026-09-04
B6785209240PressON Pedicle Screw System5209242026-09-04
B6785209250PressON Pedicle Screw System5209252026-09-04
B6785209260PressON Pedicle Screw System5209262026-09-04
B6785209270PressON Pedicle Screw System5209272026-09-04
B6785209280PressON Pedicle Screw System5209282026-09-04
B6785209290PressON Pedicle Screw System5209292026-09-04
B6785209300PressON Pedicle Screw System5209302026-09-04

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