FDA.reportPublic FDA data

PressON™

Primary DI
B7685208440
Brand
PressON™
Company
NEXUS SPINE, L.L.C.
Model
520844
Device description
Max Telescoping Rod 38mm
Published
2022-02-28
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
false

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133287000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133287000PRESSON SPINAL FIXATION SYSTEMNexus Spine, LLC2014-02-25MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7685208440PrimaryHIBCC0

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
Length38Millimeter

Sterilization Methods#

Method table
Method

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
B6785220130Tranquil-L™5220132021-12-17
B6785220140Tranquil-L™5220142021-12-17
B6785220150Tranquil-L™5220152021-12-17
B6785220160Tranquil-L™5220162021-12-17
B6785220170Tranquil-L™5220172021-12-17
B6785220180Tranquil-L™5220182021-12-17
B6785220190Tranquil-L™5220192021-12-17
B6785220200Tranquil-L™5220202021-12-17
B6785220210Tranquil-L™5220212021-12-17
B6785220220Tranquil-L™5220222021-12-17
B6785220120Tranquil-L™5220122021-12-17
B6785229040Tranquil-L™5229042021-12-17
B6785229050Tranquil-L™5229052021-12-17
B6785229060Tranquil-L™5229062021-12-17
B6785229070Tranquil-L™5229072021-12-17
B6785229080Tranquil-L™5229082021-12-17
B6785229090Tranquil-L™5229092021-12-17
B6785229100Tranquil-L™5229102021-12-17
B6785229110Tranquil-L™5229112021-12-17
B6785229120Tranquil-L™5229122021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613153143734XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153045670XIA IStryker CorporationMNH2014-12-08
07613153045700XIA IStryker CorporationMNH2014-12-08
07613153045717XIA IStryker CorporationMNH2014-12-08
07613153045731XIA IStryker CorporationMNH2014-12-08
07613153045748XIA IStryker CorporationMNH2014-12-08
07613153045755XIA IStryker CorporationMNH2014-12-08
07613153045762XIA IIStryker CorporationMNH2014-12-08
07613153045793XIA IIStryker CorporationMNH2014-12-08
07613153045847XIA IIStryker CorporationMNH2014-12-08
07613153045854XIA IIStryker CorporationMNH2014-12-08
07613153045861XIA IIStryker CorporationMNH2014-12-08
07613153045878XIA IIStryker CorporationMNH2014-12-08
07613153045885XIA IIStryker CorporationMNH2014-12-08
07613153045892XIA IIStryker CorporationMNH2014-12-08
07613153045922XIA IIStryker CorporationMNH2014-12-08
07613153045939XIA IIStryker CorporationMNH2014-12-08
07613153046011XIA STAINLESS STEELStryker CorporationMNH2014-12-08
07613153046028XIA STAINLESS STEELStryker CorporationMNH2014-12-08
07613153046042XIA STAINLESS STEELStryker CorporationMNH2014-12-08
07613153046059XIA STAINLESS STEELStryker CorporationMNH2014-12-08
07613153046066XIA STAINLESS STEELStryker CorporationMNH2014-12-08
07613153046073XIA STAINLESS STEELStryker CorporationMNH2014-12-08
07613153046080XIA STAINLESS STEELStryker CorporationMNH2014-12-08
07613153046097XIA STAINLESS STEELStryker CorporationMNH2014-12-08
07613153046103XIA STAINLESS STEELStryker CorporationMNH2014-12-08
07613153046110XIA STAINLESS STEELStryker CorporationMNH2014-12-08