PressON Pedicle Screw System

Primary DI
B6785209110
Brand
PressON Pedicle Screw System
Company
NEXUS SPINE, L.L.C.
Model
520911
Device description
Extension Coupler 10mm
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K233234000
K253331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233234000PressON Spinal Fixation SystemNexus Spine, LLC2023-10-26NKB
K253331000PressON Spinal Fixation SystemNexus Spine2025-10-14NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6785209110PrimaryHIBCC0

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6785222070Tranquil-C™5222072021-12-17
B6785222080Tranquil-C™5222082021-12-17
B6785222090Tranquil-C™5222092021-12-17
B6785222100Tranquil-C™5222102021-12-17
B6785222110Tranquil-C™5222112021-12-17
B6785222120Tranquil-C™5222122021-12-17
B6785222130Tranquil-C™5222132021-12-17
B6785222140Tranquil-C™5222142021-12-17
B6785222150Tranquil-C™5222152021-12-17
B6785222160Tranquil-C™5222162021-12-17
B6785222010Tranquil-C™5222012021-12-17
B6785222020Tranquil-C™5222022021-12-17
B6785222030Tranquil-C™5222032021-12-17
B6785222040Tranquil-C™5222042021-12-17
B6785222050Tranquil-C™5222052021-12-17
B6785222060Tranquil-C™5222062021-12-17
B6785221580Tranquil-L™5221582021-12-17
B6785221590Tranquil-L™5221592021-12-17
B6785221600Tranquil-L™5221602021-12-17
B6785221610Tranquil-L™5221612021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-25
00763000749903CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-23
00763000750510CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-23
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-23
03701313009632KHEIRONS.M.A.I.ONKB2026-10-23
03701313009649KHEIRONS.M.A.I.ONKB2026-10-23
03701313009656KHEIRONS.M.A.I.ONKB2026-10-23
03701313009663KHEIRONS.M.A.I.ONKB2026-10-23
03701313009670KHEIRONS.M.A.I.ONKB2026-10-23
03701313009687KHEIRONS.M.A.I.ONKB2026-10-23
03701313009694KHEIRONS.M.A.I.ONKB2026-10-23
03701313009700KHEIRONS.M.A.I.ONKB2026-10-23
03701313009717KHEIRONS.M.A.I.ONKB2026-10-23
03701313009724KHEIRONS.M.A.I.ONKB2026-10-23
03701313009731KHEIRONS.M.A.I.ONKB2026-10-23
03701313009748KHEIRONS.M.A.I.ONKB2026-10-23
03701313009755KHEIRONS.M.A.I.ONKB2026-10-23
03701313009762KHEIRONS.M.A.I.ONKB2026-10-23
03701313009779KHEIRONS.M.A.I.ONKB2026-10-23
03701313009786KHEIRONS.M.A.I.ONKB2026-10-23
03701313009793KHEIRONS.M.A.I.ONKB2026-10-23
03701313009809KHEIRONS.M.A.I.ONKB2026-10-23
03701313010027KHEIRONS.M.A.I.ONKB2026-10-23
03701313010034KHEIRONS.M.A.I.ONKB2026-10-23
00840466901011PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606174855PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175142PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175203PrimusSPINAL ELEMENTS, INC.NKB2026-10-22