Stowe Pedicle Screw System STO-1-8050

GUDID 00195860011225

DIA 8.00 x 50mm Solid Low-top Tulip

Evolution Spine LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00195860011225
NIH Device Record Key7178f759-c6eb-4fb2-b772-b443334a6e8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameStowe Pedicle Screw System
Version Model NumberSTO-1-8050
Catalog NumberSTO-1-8050
Company DUNS116940934
Company NameEvolution Spine LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com

Device Dimensions

Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100195860011225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

[00195860011225]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-21
Device Publish Date2021-06-12

On-Brand Devices [Stowe Pedicle Screw System]

00195860014783TORQUE LIMITING T-HANDLE 12Nm
00195860012215MIS Polyaxial ScrewDriver
00195860012208Polyaxial ScrewDriver
00195860012192DIA 8.00 x 110mm Solid MIS Tulip
00195860012185DIA 8.00 x 100mm Solid MIS Tulip
00195860012178DIA 8.00 x 90mm Solid MIS Tulip
00195860012161DIA 8.00 x 80mm Solid MIS Tulip
00195860012154DIA 8.00 x 70mm Solid MIS Tulip
00195860012147DIA 8.00 x 60mm Solid MIS Tulip
00195860012130DIA 8.00 x 55mm Solid MIS Tulip
00195860012123DIA 8.00 x 50mm Solid MIS Tulip
00195860012116DIA 8.00 x 45mm Solid MIS Tulip
00195860012109DIA 8.00 x 40mm Solid MIS Tulip
00195860012093DIA 8.00 x 35mm Solid MIS Tulip
00195860012086DIA 8.00 x 30mm Solid MIS Tulip
00195860012079DIA 8.00 x 25mm Solid MIS Tulip
00195860012062DIA 7.50 x 110mm Solid MIS Tulip
00195860012055DIA 7.50 x 100mm Solid MIS Tulip
00195860012048DIA 7.50 x 90mm Solid MIS Tulip
00195860012031DIA 7.50 x 80mm Solid MIS Tulip
00195860012024DIA 7.50 x 70mm Solid MIS Tulip
00195860012017DIA 7.50 x 60mm Solid MIS Tulip
00195860012000DIA 7.50 x 55mm Solid MIS Tulip
00195860011997DIA 7.50 x 50mm Solid MIS Tulip
00195860011980DIA 7.50 x 45mm Solid MIS Tulip
00195860011973DIA 7.50 x 40mm Solid MIS Tulip
00195860011966DIA 7.50 x 35mm Solid MIS Tulip
00195860011959DIA 7.50 x 30mm Solid MIS Tulip
00195860011942DIA 6.50 x 60mm Solid MIS Tulip
00195860011935DIA 6.50 x 55mm Solid MIS Tulip
00195860011928DIA 6.50 x 50mm Solid MIS Tulip
00195860011911DIA 6.50 x 45mm Solid MIS Tulip
00195860011904DIA 6.50 x 40mm Solid MIS Tulip
00195860011898DIA 6.50 x 35mm Solid MIS Tulip
00195860011881DIA 6.50 x 30mm Solid MIS Tulip
00195860011874DIA 5.50 x 55mm Solid MIS Tulip
00195860011867DIA 5.50 x 50mm Solid MIS Tulip
00195860011850DIA 5.50 x 45mm Solid MIS Tulip
00195860011843DIA 5.50 x 40mm Solid MIS Tulip
00195860011836DIA 5.50 x 35mm Solid MIS Tulip
00195860011829DIA 5.50 x 30mm Solid MIS Tulip
00195860011812DIA 4.50 x 55mm Solid MIS Tulip
00195860011805DIA 4.50 x 50mm Solid MIS Tulip
00195860011799DIA 4.50 x 45mm Solid MIS Tulip
00195860011782DIA 4.50 x 40mm Solid MIS Tulip
00195860011775DIA 4.50 x 35mm Solid MIS Tulip
00195860011768DIA 4.50 x 30mm Solid MIS Tulip
00195860011751DIA 4.50 x 25mm Solid MIS Tulip
00195860011744DIA 8.00 x 110mm Solid Reduction Tulip
00195860011737DIA 8.00 x 100mm Solid Reduction Tulip
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.